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Safety and Efficacy of Cunermuspir on Energy, Strength, and Fatigue in Patients With Nerve or Muscle Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04737278
Recruitment Status : Completed
First Posted : February 3, 2021
Results First Posted : April 20, 2021
Last Update Posted : April 20, 2021
Sponsor:
Information provided by (Responsible Party):
Mitosynergy LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Neuralgia
Myalgia
Interventions Drug: Cunermuspir
Other: Placebo
Enrollment 56
Recruitment Details A total of 56 met the enrollment requirements. Of these only 49 completed the study
Pre-assignment Details  
Arm/Group Title Cunermuspir Placebo
Hide Arm/Group Description

Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days.

Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients:

Organic evaporated cane juice powder, hypromellose, titanium dioxide

Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm

Placebo: same non-medical ingredients and encapsulation as Intervention 1

Period Title: Overall Study
Started 28 28
Completed 24 25
Not Completed 4 3
Reason Not Completed
Lost to Follow-up             1             1
Withdrawal by Subject             1             0
Protocol Violation             1             1
failure to complete questionnaire             1             1
Arm/Group Title Cunermuspir Placebo Total
Hide Arm/Group Description

Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days.

Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients:

Organic evaporated cane juice powder, hypromellose, titanium dioxide

Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm

Placebo: same non-medical ingredients and encapsulation as Intervention 1

Total of all reporting groups
Overall Number of Baseline Participants 28 28 56
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 28 participants 56 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
27
  96.4%
28
 100.0%
55
  98.2%
>=65 years
1
   3.6%
0
   0.0%
1
   1.8%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 28 participants 28 participants 56 participants
45.4  (13.6) 48.2  (10.4) 46.8  (12.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 28 participants 56 participants
Female
13
  46.4%
15
  53.6%
28
  50.0%
Male
15
  53.6%
13
  46.4%
28
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 28 participants 28 participants 56 participants
28 28 56
1.Primary Outcome
Title Neuromuscular Symptoms
Hide Description Quality of life was assessed by using the Individualized Neuromuscular Quality of Life Questionnaire (INQoL) Answers to symptom questions are scored from 0 to 6 or 7 with 0 being "none at all" and and 6 to 7 being "an extreme amount" There are three questions regarding pain. The pain score is (a+b+c)/19 x100. The higher the score, the greater the symptom impact.
Time Frame baseline and 28 days after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
Three patients were lost to followup.Four other patients had testing issues that the study investigators deemed them to be removed from baseline and day 28 analyses. This is why there are not 28 patients represented in baseline whereas there are in toxicology related outcome measures.
Arm/Group Title Cunermuspir Placebo
Hide Arm/Group Description:

Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days.

Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients:

Organic evaporated cane juice powder, hypromellose, titanium dioxide

Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm

Placebo: same non-medical ingredients and encapsulation as Intervention 1

Overall Number of Participants Analyzed 24 25
Mean (Standard Error)
Unit of Measure: score on a scale
baseline 36.5  (16.4) 43.5  (21.1)
Day 28 28.5  (18.6) 32.7  (23.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments test of the hypothesis that the score on day 28 is different from the baseline score in the Placebo group
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cunermuspir
Comments test of the hypothesis that the score on day 28 is different than the baseline score
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Primary Outcome
Title Platelet ATP
Hide Description Platelet ATP levels were measured as previously published in the literature.
Time Frame baseline and 28 days after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
ATP isolated from platelets. Some samples were not used for analysis due to contamination with red blood cells.
Arm/Group Title Cunermuspir Placebo
Hide Arm/Group Description:

Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days.

Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients:

Organic evaporated cane juice powder, hypromellose, titanium dioxide

Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm

Placebo: same non-medical ingredients and encapsulation as Intervention 1

Overall Number of Participants Analyzed 21 25
Mean (Standard Deviation)
Unit of Measure: nmol / E9 Platelets
baseline 43.6  (16.4) 42  (13.1)
day 28 59.2  (20.1) 51.2  (15.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cunermuspir, Placebo
Comments Day 28. Between group comparison was made using ANCOVA accounting for baseline values, no significance at p<0.05. Within group comparisons were made using the paired Student's t test.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.15
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Secondary Outcome
Title Household Chores and Neuro Muscular Sumptoms
Hide Description Physical function in performing household chores was assessed using the Revised Symptom Impact Questionnaire (SQIR) For each household chore participants are asked to check 1 of 11 boxes between "no difficulty" and "extremely difficult" No difficulty is scored as 0 and extreme difficulty with the task is scored as 10. The higher the score, the more difficulty experienced performing the chore. Friend & Bennett Arthritis Res & Therapy 2011. Household chores are just one module with 9 questions for a maximum of 90 points. These scores are summed and divided by 3. Module 2 relates to the emotional impact with only two questions for a total of 20 points. Module 3 relates to physical symptoms with a total of ten questions worth a maximum of 100 points. This score is divided by 2. The three modules are summed for a total impact score of 100 points. A score of 0 indicates absolutely no impact and a score of 100 the greatest possible impact.
Time Frame baseline and 28 days after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
Three patients were lost to followup.Four other patients had testing issues that the study investigators deemed them to be removed from baseline and day 28 analyses. This is why there are not 28 patients represented in baseline whereas there are in toxicology related outcome measures.
Arm/Group Title Cunermuspir Placebo
Hide Arm/Group Description:

Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days.

Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients:

Organic evaporated cane juice powder, hypromellose, titanium dioxide

Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm

Placebo: same non-medical ingredients and encapsulation as Intervention 1

Overall Number of Participants Analyzed 24 25
Mean (Standard Error)
Unit of Measure: units on a scale
baseline 27.6  (16.8) 34.9  (16.9)
day 28 16.7  (10.9) 29.3  (28.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cunermuspir, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cunermuspir, Placebo
Comments comparison made between placebo and Cunermuspir at baseline
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Cunermuspir, Placebo
Comments comparison made at day 28
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Cunermuspir
Comments comparison between baseline and day 28
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.07
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
4.Secondary Outcome
Title Cognition
Hide Description Cognition is the mental process of knowing, including aspects such as awareness, perception, reasoning, and judgment. The mini-mental state exam (MMSE) puts a number to "cognition." Any score of 24 or more out of a total 30 points is considered normal cognition. A test taker may be asked to orientate in space and time by recalling aspects of the physical location as well as month, day, year, and perhaps season. Simple mathematical calculations like counting backwards from 100 by seven may also be included. A complex command such as redrawing geometric figures scores six points in this exam. Since none of the participates were cognitively impaired, the investigators decided to make obtaining a perfect score on this exam an outcome measure.
Time Frame baseline and 28 days after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
Three patients were lost to followup.Four other patients had testing issues that the study investigators deemed them to be removed from baseline and day 28 analyses. This is why there are not 28 patients represented in baseline whereas there are in toxicology related outcome measures.
Arm/Group Title Cunermuspir Placebo
Hide Arm/Group Description:

Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days.

Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients:

Organic evaporated cane juice powder, hypromellose, titanium dioxide

Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm

Placebo: same non-medical ingredients and encapsulation as Intervention 1

Overall Number of Participants Analyzed 24 25
Measure Type: Number
Unit of Measure: participants with perfect score
baseline 18 16
day 28 22 18
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cunermuspir, Placebo
Comments base line between group comparisons
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.54
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cunermuspir, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.14
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
5.Secondary Outcome
Title Heart Rate
Hide Description heart rate is measured in beats per minute
Time Frame baseline and 28 days after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures
Arm/Group Title Cunermuspir Placebo
Hide Arm/Group Description:

Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days.

Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients:

Organic evaporated cane juice powder, hypromellose, titanium dioxide

Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm

Placebo: same non-medical ingredients and encapsulation as Intervention 1

Overall Number of Participants Analyzed 28 28
Mean (Standard Error)
Unit of Measure: beats per minute
baseline Number Analyzed 28 participants 28 participants
70.3  (10.8) 68.2  (8.1)
day 28 Number Analyzed 26 participants 27 participants
68.3  (9.7) 69.7  (9.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cunermuspir, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.54
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
6.Secondary Outcome
Title Diastolic Blood Pressure
Hide Description The diastolic blood pressure was measured in mm Hg
Time Frame baseline and 28 days after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures
Arm/Group Title Cunermuspir Placebo
Hide Arm/Group Description:

Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days.

Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients:

Organic evaporated cane juice powder, hypromellose, titanium dioxide

Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm

Placebo: same non-medical ingredients and encapsulation as Intervention 1

Overall Number of Participants Analyzed 28 28
Mean (Standard Error)
Unit of Measure: mm Hg
baseline Number Analyzed 28 participants 28 participants
70.5  (6.4) 75.0  (9.4)
day 28 Number Analyzed 26 participants 27 participants
69.3  (7.3) 74.6  (7.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cunermuspir, Placebo
Comments The original report from KGK Synergize/Science did not specify if the results are ANCOVA or a between group comparison at 2ay 28
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
7.Secondary Outcome
Title Systolic Blood Pressure
Hide Description Systolic blood pressure was measured in mm Hg
Time Frame baseline and 28 days after enrollment.
Hide Outcome Measure Data
Hide Analysis Population Description
For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures
Arm/Group Title Cunermuspir Placebo
Hide Arm/Group Description:

Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days.

Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients:

Organic evaporated cane juice powder, hypromellose, titanium dioxide

Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm

Placebo: same non-medical ingredients and encapsulation as Intervention 1

Overall Number of Participants Analyzed 28 28
Mean (Standard Error)
Unit of Measure: mm Hg
baseline Number Analyzed 28 participants 28 participants
111.7  (10.6) 114.6  (13.1)
day 28 Number Analyzed 26 participants 27 participants
109.5  (15.8) 112.3  (11.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cunermuspir, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.31
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
8.Secondary Outcome
Title Hemoglobin
Hide Description changes measured in g/L blood
Time Frame baseline and 28 days after enrollment.
Hide Outcome Measure Data
Hide Analysis Population Description
For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures
Arm/Group Title Cunermuspir Placebo
Hide Arm/Group Description:

Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days.

Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients:

Organic evaporated cane juice powder, hypromellose, titanium dioxide

Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm

Placebo: same non-medical ingredients and encapsulation as Intervention 1

Overall Number of Participants Analyzed 28 28
Mean (Standard Error)
Unit of Measure: g/L
baseline Number Analyzed 28 participants 28 participants
140.3  (12.9) 141.3  (12.4)
day 28 Number Analyzed 26 participants 27 participants
142.2  (14.3) 141.0  (12.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cunermuspir, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.48
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
9.Secondary Outcome
Title Hematocrit
Hide Description changes in the fraction of whole blood occupied by red blood cells measured as L/L
Time Frame baseline and 28 days after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures
Arm/Group Title Cunermuspir Placebo
Hide Arm/Group Description:

Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days.

Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients:

Organic evaporated cane juice powder, hypromellose, titanium dioxide

Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm

Placebo: same non-medical ingredients and encapsulation as Intervention 1

Overall Number of Participants Analyzed 28 28
Mean (Standard Error)
Unit of Measure: L/L
baseline Number Analyzed 28 participants 28 participants
0.411  (0.034) 0.416  (0.032)
day 28 Number Analyzed 26 participants 27 participants
0.416  (0.038) 0.415  (0.031)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cunermuspir, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.84
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
10.Secondary Outcome
Title WBC
Hide Description changes in white blood cells (WBC) measured in units of 10^9 per liter blood
Time Frame baseline and 28 days after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures
Arm/Group Title Cunermuspir Placebo
Hide Arm/Group Description:

Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days.

Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients:

Organic evaporated cane juice powder, hypromellose, titanium dioxide

Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm

Placebo: same non-medical ingredients and encapsulation as Intervention 1

Overall Number of Participants Analyzed 28 28
Mean (Standard Error)
Unit of Measure: 10^9 cells/L
baseline Number Analyzed 28 participants 28 participants
5.93  (1.57) 5.82  (1.50)
day 28 Number Analyzed 26 participants 27 participants
5.88  (1.81) 6.00  (1.34)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cunermuspir, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.63
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
11.Secondary Outcome
Title RBC
Hide Description changes in red blood cells (RBC) measured in units of 10^12 per liter blood
Time Frame baseline and 28 days after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures
Arm/Group Title Cunermuspir Placebo
Hide Arm/Group Description:

Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days.

Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients:

Organic evaporated cane juice powder, hypromellose, titanium dioxide

Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm

Placebo: same non-medical ingredients and encapsulation as Intervention 1

Overall Number of Participants Analyzed 28 28
Mean (Standard Error)
Unit of Measure: 10^12 cells/L
baseline Number Analyzed 28 participants 28 participants
4.76  (0.38) 4.74  (0.38)
day 28 Number Analyzed 26 participants 27 participants
4.82  (0.41) 4.73  (0.38)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cunermuspir, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
12.Secondary Outcome
Title MCV
Hide Description changes in mean corpuscular volume (MCV) measured in units of fL
Time Frame baseline and 28 days after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
Three patients were lost to followup.Four other patients had testing issues that the study investigators deemed them to be removed from baseline and day 28 analyses. This is why there are not 28 patients represented in baseline whereas there are in toxicology related outcome measures.
Arm/Group Title Cunermuspir Placebo
Hide Arm/Group Description:

Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days.

Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients:

Organic evaporated cane juice powder, hypromellose, titanium dioxide

Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm

Placebo: same non-medical ingredients and encapsulation as Intervention 1

Overall Number of Participants Analyzed 28 28
Mean (Standard Error)
Unit of Measure: fempto liter per cell
baseline Number Analyzed 28 participants 28 participants
86.2  (3.9) 87.7  (3.1)
day 28 Number Analyzed 26 participants 27 participants
86.4  (4.3) 87.7  (3.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cunermuspir, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
13.Secondary Outcome
Title MCH
Hide Description changes in mean corpuscular hemoglobin, measured in units of pg, the average amount of hemoglobin in a single RBC
Time Frame baseline and 28 days after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures
Arm/Group Title Cunermuspir Placebo
Hide Arm/Group Description:

Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days.

Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients:

Organic evaporated cane juice powder, hypromellose, titanium dioxide

Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm

Placebo: same non-medical ingredients and encapsulation as Intervention 1

Overall Number of Participants Analyzed 28 28
Mean (Standard Error)
Unit of Measure: pg per cell
baseline Number Analyzed 28 participants 28 participants
29.5  (1.64) 29.81  (1.36)
day 28 Number Analyzed 26 participants 27 participants
29.48  (1.69) 29.86  (1.29)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cunermuspir, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
14.Secondary Outcome
Title MCHC
Hide Description mean corpuscular hemoglobin concentration is the concentration of hemoglobin in a single RBC measured in units of g/L
Time Frame baseline and 28 days after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures
Arm/Group Title Cunermuspir Placebo
Hide Arm/Group Description:

Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days.

Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients:

Organic evaporated cane juice powder, hypromellose, titanium dioxide

Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm

Placebo: same non-medical ingredients and encapsulation as Intervention 1

Overall Number of Participants Analyzed 28 28
Mean (Standard Error)
Unit of Measure: g/L
baseline Number Analyzed 28 participants 28 participants
342.4  (8.2) 339.9  (7.8)
day 28 Number Analyzed 26 participants 27 participants
341.2  (6.4) 340.5  (5.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cunermuspir, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.48
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
15.Secondary Outcome
Title RDW
Hide Description changes in the RBC distribution width (RDW) are reported in units of percentage (%)
Time Frame baseline and 28 days after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures
Arm/Group Title Cunermuspir Placebo
Hide Arm/Group Description:

Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days.

Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients:

Organic evaporated cane juice powder, hypromellose, titanium dioxide

Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm

Placebo: same non-medical ingredients and encapsulation as Intervention 1

Overall Number of Participants Analyzed 28 28
Mean (Standard Error)
Unit of Measure: red cell distribution width %
baseline Number Analyzed 28 participants 28 participants
13.78  (0.70) 13.80  (0.50)
day 28 Number Analyzed 26 participants 27 participants
13.77  (0.63) 13.93  (0.58)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cunermuspir, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.06
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
16.Secondary Outcome
Title Platelets
Hide Description changes in the platelet counts are reported in units of 10^9 per liter blood
Time Frame baseline and 28 days after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
By day 28 three participants were lost to followup: two in the Cunermuspir group and one in the placebo group. There were issues in handling of one platelet sample in the Cunermuspir group. This brings the number in the Cunermuspir group down to 25 on day 28. For technical reasons, platelet data are missing for subject 021. All other blood cell data are present in this report of data.
Arm/Group Title Cunermuspir Placebo
Hide Arm/Group Description:

Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days.

Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients:

Organic evaporated cane juice powder, hypromellose, titanium dioxide

Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm

Placebo: same non-medical ingredients and encapsulation as Intervention 1

Overall Number of Participants Analyzed 28 28
Mean (Standard Error)
Unit of Measure: 10^9 platelets/L
baseline Number Analyzed 28 participants 28 participants
250  (62) 266  (71)
day 28 Number Analyzed 25 participants 27 participants
255  (65) 269  (69)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cunermuspir, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.02
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
17.Secondary Outcome
Title Neutrophils
Hide Description changes in neutrophils are reported in units of 10^9 per liter blood
Time Frame baseline and 28 days after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures
Arm/Group Title Cunermuspir Placebo
Hide Arm/Group Description:

Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days.

Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients:

Organic evaporated cane juice powder, hypromellose, titanium dioxide

Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm

Placebo: same non-medical ingredients and encapsulation as Intervention 1

Overall Number of Participants Analyzed 28 28
Mean (Standard Error)
Unit of Measure: 10^9 cells/L
baseline Number Analyzed 28 participants 28 participants
3.28  (1.06) 3.35  (1.13)
day 28 Number Analyzed 26 participants 27 participants
3.15  (1.19) 3.60  (1.13)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cunermuspir, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo
Comments comparison of neutrophils from baseline to day 28
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
18.Secondary Outcome
Title Lymphocyte
Hide Description changes in lymphocytes are reported in units of 10^9 per liter blood
Time Frame baseline and 28 days after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures
Arm/Group Title Cunermuspir Placebo
Hide Arm/Group Description:

Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days.

Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients:

Organic evaporated cane juice powder, hypromellose, titanium dioxide

Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm

Placebo: same non-medical ingredients and encapsulation as Intervention 1

Overall Number of Participants Analyzed 28 28
Mean (Standard Error)
Unit of Measure: 10^9 cells/L
baseline Number Analyzed 28 participants 28 participants
2.01  (0.64) 1.83  (0.51)
day 28 Number Analyzed 26 participants 27 participants
2.04  (0.72) 1.74  (0.51)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cunermuspir, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
19.Secondary Outcome
Title Monocyte
Hide Description changes in monocytes are reported in units of 10^9 per liter blood
Time Frame baseline and 28 days after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures
Arm/Group Title Cunermuspir Placebo
Hide Arm/Group Description:

Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days.

Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients:

Organic evaporated cane juice powder, hypromellose, titanium dioxide

Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm

Placebo: same non-medical ingredients and encapsulation as Intervention 1

Overall Number of Participants Analyzed 28 28
Mean (Standard Error)
Unit of Measure: 10^9 cells/L
baseline Number Analyzed 28 participants 28 participants
0.450  (0.137) 0.475  (0.140)
day 28 Number Analyzed 26 participants 27 participants
0.473  (0.176) 0.500  (0.124)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cunermuspir, Placebo
Comments comparison of baseline values
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.47
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cunermuspir, Placebo
Comments comparison performed on data from day 28
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.24
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
20.Secondary Outcome
Title Eosinophil
Hide Description changes in eosinophils are reported in units of 10^9 cells per liter blood
Time Frame baseline and 28 days after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures
Arm/Group Title Cunermuspir Placebo
Hide Arm/Group Description:

Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days.

Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients:

Organic evaporated cane juice powder, hypromellose, titanium dioxide

Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm

Placebo: same non-medical ingredients and encapsulation as Intervention 1

Overall Number of Participants Analyzed 28 28
Mean (Standard Error)
Unit of Measure: 10^9 cells/L
baseline Number Analyzed 28 participants 28 participants
0.154  (0.074) 0.143  (0.063)
day 28 Number Analyzed 26 participants 27 participants
0.181  (0.110) 0.130  (0.072)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cunermuspir, Placebo
Comments comparison of eosinophil counts at day 28
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.11
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
21.Secondary Outcome
Title Basophil
Hide Description changes in basophils are reported in units of 10^9 cells per liter blood
Time Frame baseline and 28 days after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures
Arm/Group Title Cunermuspir Placebo
Hide Arm/Group Description:

Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days.

Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients:

Organic evaporated cane juice powder, hypromellose, titanium dioxide

Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm

Placebo: same non-medical ingredients and encapsulation as Intervention 1

Overall Number of Participants Analyzed 28 28
Mean (Standard Error)
Unit of Measure: 10^9 cells/L
baseline Number Analyzed 28 participants 28 participants
0.0107  (0.0315) 0.0071  (0.0262)
day 28 Number Analyzed 26 participants 27 participants
0.0077  (0.0272) 0.0074  (0.0267)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cunermuspir, Placebo
Comments The day 28 basophil counts on day 28 were compared between the two arms of this study.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.98
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
22.Secondary Outcome
Title NLR
Hide Description Changes in the neutrophil to lymphocyte ratio (NLR) are reported as a dimensionless fraction of 1
Time Frame baseline and 28 days after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures
Arm/Group Title Cunermuspir Placebo
Hide Arm/Group Description:

Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days.

Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients:

Organic evaporated cane juice powder, hypromellose, titanium dioxide

Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm

Placebo: same non-medical ingredients and encapsulation as Intervention 1

Overall Number of Participants Analyzed 28 28
Mean (Standard Error)
Unit of Measure: dimensionaless units
baseline Number Analyzed 28 participants 28 participants
1.77  (0.15) 1.90  (0.13)
day 28 Number Analyzed 26 participants 27 participants
1.67  (0.14) 2.24  (0.19)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cunermuspir, Placebo
Comments

All other statistical analyses were performed by KGK Synergize. This site was used to determine that the NLR were normally distributed https://www.gigacalculator.com/calculators/normality-test-calculator.php

Because these data fulfilled the assumptions of ANOVA, the data were analyzed using this site:

http://vassarstats.net/anova2u.html

Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.025
Comments This p value is for the treatment source. Visits (p=0.422) and visits x treatments (p=0.153) did not meet the threshold of significance.
Method ANOVA
Comments [Not Specified]
23.Secondary Outcome
Title Glucose
Hide Description changes in blood glucose are reported in units of mmol per liter
Time Frame baseline and 28 days after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
In this population the initial screening was considered the baseline for all blood chemistry parameters. Three of the the participants were lost to followup or withdrew from the study
Arm/Group Title Cunermuspir Placebo
Hide Arm/Group Description:

Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days.

Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients:

Organic evaporated cane juice powder, hypromellose, titanium dioxide

Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm

Placebo: same non-medical ingredients and encapsulation as Intervention 1

Overall Number of Participants Analyzed 28 28
Mean (Standard Error)
Unit of Measure: mmol/L
baseline Number Analyzed 28 participants 28 participants
5.12  (0.55) 5.30  (0.42)
day 28 Number Analyzed 26 participants 27 participants
5.25  (0.44) 5.24  (0.48)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cunermuspir
Comments Comparison of blood glucose in the Cunermuspir arm between enrollment baseline and day 28.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.06
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo
Comments Comparison of enrollment baseline blood glucose and day 28 in the placebo arm
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.04
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Cunermuspir, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.92
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
24.Secondary Outcome
Title Urea
Hide Description changes in renal function as measured by blood urea are reported in units of mmol per liter
Time Frame baseline and 28 days after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures
Arm/Group Title Cunermuspir Placebo
Hide Arm/Group Description:

Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days.

Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients:

Organic evaporated cane juice powder, hypromellose, titanium dioxide

Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm

Placebo: same non-medical ingredients and encapsulation as Intervention 1

Overall Number of Participants Analyzed 28 28
Mean (Standard Error)
Unit of Measure: mmol/L
baseline Number Analyzed 28 participants 28 participants
5.16  (1.13) 5.33  (1.25)
day 28 Number Analyzed 26 participants 27 participants
5.05  (1.57) 5.26  (1.08)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cunermuspir, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.51
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
25.Secondary Outcome
Title Creatinine
Hide Description changes in creatinine are reported in units of micromol per liter
Time Frame baseline and 28 days after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures
Arm/Group Title Cunermuspir Placebo
Hide Arm/Group Description:

Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days.

Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients:

Organic evaporated cane juice powder, hypromellose, titanium dioxide

Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm

Placebo: same non-medical ingredients and encapsulation as Intervention 1

Overall Number of Participants Analyzed 28 28
Mean (Standard Error)
Unit of Measure: micromol/L
baseline Number Analyzed 28 participants 28 participants
72.2  (11.6) 72.9  (16.0)
day 28 Number Analyzed 26 participants 27 participants
72.3  (13.7) 73.7  (15.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cunermuspir, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.38
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
26.Secondary Outcome
Title eGFR
Hide Description changes in the estimated glomerular filtration rate (eGFR) are reported in units of mL/min/1.73m^2
Time Frame baseline and 28 days after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures
Arm/Group Title Cunermuspir Placebo
Hide Arm/Group Description:

Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days.

Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients:

Organic evaporated cane juice powder, hypromellose, titanium dioxide

Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm

Placebo: same non-medical ingredients and encapsulation as Intervention 1

Overall Number of Participants Analyzed 28 28
Mean (Standard Error)
Unit of Measure: mL/min/1.73 m^2
baseline Number Analyzed 28 participants 28 participants
90.4  (17.3) 88.8  (16.2)
day 28 Number Analyzed 26 participants 27 participants
91.2  (18.3) 85.9  (15.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cunermuspir, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
27.Secondary Outcome
Title Sodium
Hide Description changes in plasma sodium are reported in units of mmol per liter, reference range is 133-146 mEq/L, same as mM/L bloodbook.com
Time Frame baseline and 28 days after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures
Arm/Group Title Cunermuspir Placebo
Hide Arm/Group Description:

Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days.

Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients:

Organic evaporated cane juice powder, hypromellose, titanium dioxide

Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm

Placebo: same non-medical ingredients and encapsulation as Intervention 1

Overall Number of Participants Analyzed 28 28
Mean (Standard Error)
Unit of Measure: mmol/L
baseline Number Analyzed 28 participants 28 participants
143.39  (2.25) 143.14  (2.16)
day 28 Number Analyzed 26 participants 27 participants
142.62  (2.47) 141.89  (2.12)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cunermuspir, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.23
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cunermuspir
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.18
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo
Comments Blood sodium concentration between baseline and day 28 in the Placebo group.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
28.Secondary Outcome
Title Potassium
Hide Description changes in plasma potassium are reported in units of mmol per liter, reference value 3.5-5.4 mmol per liter, bloodbook.com
Time Frame baseline and 28 days after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
The study sponsor is of the opinion that these participants were dehydrated when they started the study. They were instructed to drink more water. Three of the 56 that started the study were lost to followup or withdrew.
Arm/Group Title Cunermuspir Placebo
Hide Arm/Group Description:

Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days.

Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients:

Organic evaporated cane juice powder, hypromellose, titanium dioxide

Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm

Placebo: same non-medical ingredients and encapsulation as Intervention 1

Overall Number of Participants Analyzed 28 28
Mean (Standard Error)
Unit of Measure: mmol/L
baseline Number Analyzed 28 participants 28 participants
4.86  (0.45) 4.84  (0.45)
day 28 Number Analyzed 26 participants 27 participants
4.44  (0.43) 4.39  (0.39)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cunermuspir, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.58
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cunermuspir
Comments comparison of blood potassium concentration upon enrollment and day 28 in the Cunermuspir participants
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo
Comments comparison of blood potassium concentrations from enrollment to day 28 in participants in the Placebo arm.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
29.Secondary Outcome
Title Chloride
Hide Description changes in plasma chloride are reported in uits of mmol per liter The reference range is 98-106 mmol per liter, bloodbook.com
Time Frame baseline and 28 days after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
Enrollment pre-screening values are taken as the baseline. The study sponsor was of the opinion that these participants started the study dehydrated. Of the original 56 three were lost to followup or withdrew.
Arm/Group Title Cunermuspir Placebo
Hide Arm/Group Description:

Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days.

Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients:

Organic evaporated cane juice powder, hypromellose, titanium dioxide

Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm

Placebo: same non-medical ingredients and encapsulation as Intervention 1

Overall Number of Participants Analyzed 28 28
Mean (Standard Error)
Unit of Measure: mmol/L
baseline Number Analyzed 28 participants 28 participants
106.14  (2.12) 106.43  (2.27)
day 28 Number Analyzed 26 participants 27 participants
105.08  (2.23) 105.15  (1.99)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cunermuspir, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.87
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cunermuspir
Comments comparison between baseline and day 28 chloride concentrations in the Cunermuspir group
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo
Comments comparison of blood chloride concentrations between baseline and day 28 in Placebo Arm participants
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
30.Secondary Outcome
Title Bilirubin
Hide Description changes in total bilirubin are reported in units of micro moles per liter. Direct: up to 0.4 mg/dL, Total: up to 1.0 mg/dL bloodbook.com, Converts to 6.84-17.1 micro moles per liter. https://unitslab.com/node/37
Time Frame baseline and 28 days after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures
Arm/Group Title Cunermuspir Placebo
Hide Arm/Group Description:

Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days.

Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients:

Organic evaporated cane juice powder, hypromellose, titanium dioxide

Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm

Placebo: same non-medical ingredients and encapsulation as Intervention 1

Overall Number of Participants Analyzed 28 28
Mean (Standard Error)
Unit of Measure: micromol/L
baseline Number Analyzed 28 participants 28 participants
11.0  (5.9) 9.3  (3.5)
day 28 Number Analyzed 26 participants 27 participants
11.2  (5.9) 9.9  (4.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cunermuspir, Placebo
Comments Bilirubin concentrations between Placebo and Cunermuspir compared at day 28
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.36
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cunermuspir
Comments comparison of bilirubin concentrations between baseline and day 28 in the Cunermuspir Arm
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.72
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments Wilcoxon Signed-Rank
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo
Comments bilirubin concentrations compared between baseline and Day 28 in the Placebo Arm
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.35
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
31.Secondary Outcome
Title ALT
Hide Description changes in the liver enzyme alanine aminotransferase (ALT) in the blood are reported as units per liter Reference range 1 - 21 units/L bloodbook.com
Time Frame baseline and 28 days after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures
Arm/Group Title Cunermuspir Placebo
Hide Arm/Group Description:

Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days.

Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients:

Organic evaporated cane juice powder, hypromellose, titanium dioxide

Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm

Placebo: same non-medical ingredients and encapsulation as Intervention 1

Overall Number of Participants Analyzed 28 28
Mean (Standard Error)
Unit of Measure: U/L
baseline Number Analyzed 28 participants 28 participants
27.6  (12.8) 28.5  (16.3)
day 28 Number Analyzed 26 participants 27 participants
28.2  (15.5) 28.4  (15.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cunermuspir, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.95
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cunermuspir
Comments comparison between baseline and day 28 values in Cunermuspir group
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo
Comments comparison between baseline and day 28 values for the Placebo Arm
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
32.Secondary Outcome
Title AST
Hide Description changes in the liver enzyme aspartate aminotransferase (AST) in the blood are reported as units per liter Reference range 7 - 27 units/L bloodbook.com
Time Frame baseline and 28 days after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures
Arm/Group Title Cunermuspir Placebo
Hide Arm/Group Description:

Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days.

Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients:

Organic evaporated cane juice powder, hypromellose, titanium dioxide

Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm

Placebo: same non-medical ingredients and encapsulation as Intervention 1

Overall Number of Participants Analyzed 28 28
Mean (Standard Error)
Unit of Measure: U/L
baseline Number Analyzed 28 participants 28 participants
23.0  (4.9) 23.1  (6.3)
day 28 Number Analyzed 26 participants 27 participants
24.2  (6.2) 25.8  (9.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cunermuspir, Placebo
Comments comparison of AST enzyme activity in blood on day 28 between Cunermuspir and Placebo
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.62
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cunermuspir
Comments baseline to day 28 comparison
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.24
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo
Comments baseline to day 28 comparison of AST activity in Placebo group
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.11
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
33.Secondary Outcome
Title GGT
Hide Description changes in the liver enzyme gamma-glutamyl transferase in the blood are reported as units per liter
Time Frame baseline and 28 days after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
Three participants were lost to followup on day 28. For toxicology outcome measures the investigators included all 28 participants in each group at baseline as well as data for the 26 (Cunermuspir) and 27 (Placebo) remaining at day 28. The investigators considered these data valid in spite of issues with the questionnaires of other outcome measures
Arm/Group Title Cunermuspir Placebo
Hide Arm/Group Description:

Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days.

Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients:

Organic evaporated cane juice powder, hypromellose, titanium dioxide

Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm

Placebo: same non-medical ingredients and encapsulation as Intervention 1

Overall Number of Participants Analyzed 28 28
Mean (Standard Error)
Unit of Measure: U/L
baseline Number Analyzed 28 participants 28 participants
20.9  (13.6) 28.6  (36.6)
day 28 Number Analyzed 26 participants 27 participants
24.0  (18.1) 25.6  (23.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cunermuspir, Placebo
Comments comparison between placebo and Cunermuspir at day 28
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.11
Comments Comparison of GGT activities in blood of two arms: Cunermuspir and Placebo on Day 28
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cunermuspir
Comments Comparison of GGT activities in participants' blood at baseline and on day 28
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method Wilcoxon Signed Rank
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo
Comments Comparison of GGT activity in blood between Placebo Arm participants at baseline and on day 28
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.97
Comments [Not Specified]
Method Wilcoxon Signed-Rank
Comments [Not Specified]
34.Secondary Outcome
Title Copper
Hide Description changes in copper concentration in the blood are reported in units of micro moles per liter
Time Frame baseline and 28 days after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 56 enrolled in the study three were lost to followup or dropped out.
Arm/Group Title Cunermuspir Placebo
Hide Arm/Group Description:

Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days.

Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients:

Organic evaporated cane juice powder, hypromellose, titanium dioxide

Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm

Placebo: same non-medical ingredients and encapsulation as Intervention 1

Overall Number of Participants Analyzed 28 28
Mean (Standard Error)
Unit of Measure: U/L
baseline Number Analyzed 28 participants 28 participants
16.18  (2.42) 17.62  (2.51)
day 28 Number Analyzed 26 participants 27 participants
16.6  (2.8) 17.57  (2.89)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cunermuspir, Placebo
Comments Between group comparisons were made using ANCOVA
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Cunermuspir
Comments comparison of baseline with day 28
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.10
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo
Comments comparison between baseline and day 28 serum copper concentrations in the Placebo Arm
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.89
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame 28 days
Adverse Event Reporting Description All treatment--emergent adverse events (AEs) are listed and MedDRA--coded to obtain the MedDRA Preferred Term and Organ System ("body system"). The nature, incidence, severity and causality were AEs were summarized in a frequency table, by body system and treatment. The proportion of subjects experiencing one or more AEs were compared between groups, separately for each body system and for all AEs combined.
 
Arm/Group Title Cunermuspir Placebo
Hide Arm/Group Description

Cunermuspir (Copper Niacin Chelate) 6.06mg per capsule. Non--medicinal ingredients: Organic evaporated cane juice powder, hypromellose, titanium dioxide Two doses per day: one with the morning meal and the other with a mid afternoon snack. The study duration was 28 days.

Cunermuspir: Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients:

Organic evaporated cane juice powder, hypromellose, titanium dioxide

Organic evaporated cane juice powder, hypromellose, titanium dioxide. Same dosing as Cunermuspir arm

Placebo: same non-medical ingredients and encapsulation as Intervention 1

All-Cause Mortality
Cunermuspir Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/28 (0.00%)      0/28 (0.00%)    
Hide Serious Adverse Events
Cunermuspir Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/28 (0.00%)      0/28 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cunermuspir Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/26 (23.08%)      7/27 (25.93%)    
Gastrointestinal disorders     
nasea  1 [1]  4/26 (15.38%)  4 3/27 (11.11%)  3
Infections and infestations     
seasonal respiratory infections  1 [2]  2/26 (7.69%)  2 4/27 (14.81%)  5
Nervous system disorders     
head ache  1 [3]  2/26 (7.69%)  2 1/27 (3.70%)  1
Skin and subcutaneous tissue disorders     
moderate dermatitis  1  1/26 (3.85%)  1 0/27 (0.00%)  0
1
Term from vocabulary, MedDRA (10.0)
Indicates events were collected by systematic assessment
[1]
also includes upset stomach, dry mouth, and dry mouth
[2]
includes sinusitis, common cold, and flu
[3]
the study investigators concluded that on of the two head ache in the Cunermuspir Arm may have been related to the study product.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The study PI (Dale Wilson) retired soon after the study was completed. KGK Synergize has undergone reorganization as KGK Science. The original intent was to publish the study results in a peer review journal.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Barbara Leinweber, PhD
Organization: BDL Biochemistry, consultant for Mitosynergy
Phone: (520)334-5444
EMail: barb@bdlbiochem.com
Layout table for additonal information
Responsible Party: Mitosynergy LLC
ClinicalTrials.gov Identifier: NCT04737278    
Other Study ID Numbers: 13MFHM
First Submitted: January 25, 2021
First Posted: February 3, 2021
Results First Submitted: February 12, 2021
Results First Posted: April 20, 2021
Last Update Posted: April 20, 2021