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Beneficial Effects of Quercetin in Chronic Obstructive Pulmonary Disease (COPD) (Quercetin)

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ClinicalTrials.gov Identifier: NCT01708278
Recruitment Status : Completed
First Posted : October 16, 2012
Results First Posted : December 26, 2016
Last Update Posted : December 26, 2016
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Quercegen Pharmaceuticals
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Umadevi S. Sajjan, University of Michigan

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Chronic Obstructive Pulmonary Disease
Interventions Drug: Quercetin
Other: Placebo - sugar chew
Enrollment 9
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sugar Chew- Cohort 1 Quercetin 1-Cohort 1 Quercetin 2-Cohort 2 Quercetin 3-Cohort 3 Sugar Chew-Cohort 2 Sugar Chew-Cohort 3
Hide Arm/Group Description

contains 350 mg of vitamin C and 10 mg niacin

Placebo - sugar chew: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take placebo (sugar chew containing 350 mg of vitamin C and 10 mg niacin)

Quercetin chew containing 500 mg quercetin, 350 mg vitamin C and 10 mg niacin

Quercetin: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take one of the following for 1 week

  1. Quercetin 500 mg/350 mg of vitamin C and 10 mg niacin
  2. Quercetin 1000 mg/350 mg of vitamin C and 10 mg niacin
  3. Quercetin 2000 mg/350 mg of vitamin C and 10 mg niacin

Quercetin chew containing 1000 mg quercetin, 350 mg vitamin C and 10 mg niacin

Quercetin: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take one of the following for 1 week

  1. Quercetin 500 mg/350 mg of vitamin C and 10 mg niacin
  2. Quercetin 1000 mg/350 mg of vitamin C and 10 mg niacin
  3. Quercetin 2000 mg/350 mg of vitamin C and 10 mg niacin

Quercetin chew containing 2000 mg quercetin, 350 mg vitamin C and 10 mg niacin

Quercetin: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take one of the following for 1 week

  1. Quercetin 500 mg/350 mg of vitamin C and 10 mg niacin
  2. Quercetin 1000 mg/350 mg of vitamin C and 10 mg niacin
  3. Quercetin 2000 mg/350 mg of vitamin C and 10 mg niacin

contains 350 mg of vitamin C and 10 mg niacin

Placebo - sugar chew: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take placebo (sugar chew containing 350 mg of vitamin C and 10 mg niacin)

contains 350 mg of vitamin C and 10 mg niacin

Placebo - sugar chew: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take placebo (sugar chew containing 350 mg of vitamin C and 10 mg niacin)

Period Title: Overall Study
Started 1 2 2 2 1 1
Completed 1 2 2 2 1 1
Not Completed 0 0 0 0 0 0
Arm/Group Title Sugar Chew- Cohort 1 Quercetin 1-Cohort 1 Quercetin 2-Cohort 2 Quercetin 3-Cohort 3 Sugar Chew-Cohort 2 Sugar Chew-Cohort 3 Total
Hide Arm/Group Description

contains 350 mg of vitamin C and 10 mg niacin

Placebo - sugar chew: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take placebo (sugar chew containing 350 mg of vitamin C and 10 mg niacin)

Quercetin chew containing 500 mg quercetin, 350 mg vitamin C and 10 mg niacin

Quercetin: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take one of the following for 1 week

  1. Quercetin 500 mg/350 mg of vitamin C and 10 mg niacin
  2. Quercetin 1000 mg/350 mg of vitamin C and 10 mg niacin
  3. Quercetin 2000 mg/350 mg of vitamin C and 10 mg niacin

Quercetin chew containing 1000 mg quercetin, 350 mg vitamin C and 10 mg niacin

Quercetin: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take one of the following for 1 week

  1. Quercetin 500 mg/350 mg of vitamin C and 10 mg niacin
  2. Quercetin 1000 mg/350 mg of vitamin C and 10 mg niacin
  3. Quercetin 2000 mg/350 mg of vitamin C and 10 mg niacin

Quercetin chew containing 2000 mg quercetin, 350 mg vitamin C and 10 mg niacin

Quercetin: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take one of the following for 1 week

  1. Quercetin 500 mg/350 mg of vitamin C and 10 mg niacin
  2. Quercetin 1000 mg/350 mg of vitamin C and 10 mg niacin
  3. Quercetin 2000 mg/350 mg of vitamin C and 10 mg niacin

contains 350 mg of vitamin C and 10 mg niacin

Placebo - sugar chew: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take placebo (sugar chew containing 350 mg of vitamin C and 10 mg niacin)

contains 350 mg of vitamin C and 10 mg niacin

Placebo - sugar chew: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take placebo (sugar chew containing 350 mg of vitamin C and 10 mg niacin)

Total of all reporting groups
Overall Number of Baseline Participants 1 2 2 2 1 1 9
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Age 40 - 80 years Number Analyzed 1 participants 2 participants 2 participants 2 participants 1 participants 1 participants 9 participants
1 2 2 2 1 1 9
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 2 participants 2 participants 2 participants 1 participants 1 participants 9 participants
Female
1
 100.0%
1
  50.0%
0
   0.0%
1
  50.0%
1
 100.0%
0
   0.0%
4
  44.4%
Male
0
   0.0%
1
  50.0%
2
 100.0%
1
  50.0%
0
   0.0%
1
 100.0%
5
  55.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1 participants 2 participants 2 participants 2 participants 1 participants 1 participants 9 participants
1 2 2 2 1 1 9
Lung Function   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1 participants 2 participants 2 participants 2 participants 1 participants 1 participants 9 participants
1 2 2 2 1 1 9
[1]
Measure Description: Lung Function FEV1 between 35 and 80% predicted
1.Primary Outcome
Title Participants Who Experienced Safety Concerns, Where Safety Concerns of Quercetin Supplementation is Indicated by Significant Change From Baseline Measures of Tests Indicated Below in Outcome Measure Description
Hide Description

Note: If values for any of the measures indicated here were found, the participant would be indicated as a participant with a safety concern, and values for that particular measure would be posted specifically, but since none of the participants experienced these outlying values, results of all tests are expressed here as a composite function.

PULMONARY FUNCTION TEST:

FEV1% of predicted: decline by >20% from baseline COMPLETE BLOOD COUNTS: WBC (cells)/mm3 : <2000, Platelets (cells)/mm3: <25,000, Hemoglobin (g/dL): <7.0 COMPREHENSIVE METABOLIC PROFILE (study drug related):Sodium (mmol/L): <125 or >148, Potassium (mmol/L): < 3.0 or > 6.0, Calcium (mmol/L): <7.4 or > 11.5, LIVER FUNCTION TESTS INCREASE BY FACTOR: Enzymes ALT, AST, and Alkaline phosphate, Total bilirubin: for any of these a value >3X upper limit of normal

Time Frame One week in Phase I safety study
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sugar Chew- Cohort 1 Quercetin 1-Cohort 1 Quercetin 2-Cohort 2 Quercetin 3-Cohort 3 Sugar Chew-Cohort 2 Sugar Chew-Cohort 3
Hide Arm/Group Description:

contains 350 mg of vitamin C and 10 mg niacin

Placebo - sugar chew: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take placebo (sugar chew containing 350 mg of vitamin C and 10 mg niacin)

Quercetin chew containing 500 mg quercetin, 350 mg vitamin C and 10 mg niacin

Quercetin: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take one of the following for 1 week

  1. Quercetin 500 mg/350 mg of vitamin C and 10 mg niacin
  2. Quercetin 1000 mg/350 mg of vitamin C and 10 mg niacin
  3. Quercetin 2000 mg/350 mg of vitamin C and 10 mg niacin

Quercetin chew containing 1000 mg quercetin, 350 mg vitamin C and 10 mg niacin

Quercetin: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take one of the following for 1 week

  1. Quercetin 500 mg/350 mg of vitamin C and 10 mg niacin
  2. Quercetin 1000 mg/350 mg of vitamin C and 10 mg niacin
  3. Quercetin 2000 mg/350 mg of vitamin C and 10 mg niacin

Quercetin chew containing 2000 mg quercetin, 350 mg vitamin C and 10 mg niacin

Quercetin: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take one of the following for 1 week

  1. Quercetin 500 mg/350 mg of vitamin C and 10 mg niacin
  2. Quercetin 1000 mg/350 mg of vitamin C and 10 mg niacin
  3. Quercetin 2000 mg/350 mg of vitamin C and 10 mg niacin

contains 350 mg of vitamin C and 10 mg niacin

Placebo - sugar chew: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take placebo (sugar chew containing 350 mg of vitamin C and 10 mg niacin)

contains 350 mg of vitamin C and 10 mg niacin

Placebo - sugar chew: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take placebo (sugar chew containing 350 mg of vitamin C and 10 mg niacin)

Overall Number of Participants Analyzed 1 2 2 2 1 1
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Time Frame 14 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sugar Chew-Cohort 1 Quercetin 1-Cohort 1 Quercetin 2-Cohort 2 Quercetin 3-Cohort 3 Sugar Chew-Cohort 2 Sugar Chew-Cohort 3
Hide Arm/Group Description

contains 350 mg of vitamin C and 10 mg niacin

Placebo - sugar chew: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take placebo (sugar chew containing 350 mg of vitamin C and 10 mg niacin)

Quercetin chew containing 500 mg quercetin, 350 mg vitamin C and 10 mg niacin

Quercetin: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take one of the following for 1 week

  1. Quercetin 500 mg/350 mg of vitamin C and 10 mg niacin
  2. Quercetin 1000 mg/350 mg of vitamin C and 10 mg niacin
  3. Quercetin 2000 mg/350 mg of vitamin C and 10 mg niacin

Quercetin chew containing 1000 mg quercetin, 350 mg vitamin C and 10 mg niacin

Quercetin: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take one of the following for 1 week

  1. Quercetin 500 mg/350 mg of vitamin C and 10 mg niacin
  2. Quercetin 1000 mg/350 mg of vitamin C and 10 mg niacin
  3. Quercetin 2000 mg/350 mg of vitamin C and 10 mg niacin

Quercetin chew containing 2000 mg quercetin, 350 mg vitamin C and 10 mg niacin

Quercetin: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take one of the following for 1 week

  1. Quercetin 500 mg/350 mg of vitamin C and 10 mg niacin
  2. Quercetin 1000 mg/350 mg of vitamin C and 10 mg niacin
  3. Quercetin 2000 mg/350 mg of vitamin C and 10 mg niacin

contains 350 mg of vitamin C and 10 mg niacin

Placebo - sugar chew: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take placebo (sugar chew containing 350 mg of vitamin C and 10 mg niacin)

contains 350 mg of vitamin C and 10 mg niacin

Placebo - sugar chew: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take placebo (sugar chew containing 350 mg of vitamin C and 10 mg niacin)

All-Cause Mortality
Sugar Chew-Cohort 1 Quercetin 1-Cohort 1 Quercetin 2-Cohort 2 Quercetin 3-Cohort 3 Sugar Chew-Cohort 2 Sugar Chew-Cohort 3
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Sugar Chew-Cohort 1 Quercetin 1-Cohort 1 Quercetin 2-Cohort 2 Quercetin 3-Cohort 3 Sugar Chew-Cohort 2 Sugar Chew-Cohort 3
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/2 (0.00%)   0/2 (0.00%)   0/2 (0.00%)   0/1 (0.00%)   0/1 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Sugar Chew-Cohort 1 Quercetin 1-Cohort 1 Quercetin 2-Cohort 2 Quercetin 3-Cohort 3 Sugar Chew-Cohort 2 Sugar Chew-Cohort 3
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/1 (100.00%)   2/2 (100.00%)   2/2 (100.00%)   1/2 (50.00%)   1/1 (100.00%)   1/1 (100.00%) 
Gastrointestinal disorders             
Heart burn, GERD   1/1 (100.00%)  1/2 (50.00%)  1/2 (50.00%)  0/2 (0.00%)  0/0  0/1 (0.00%) 
Nausea   0/1 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/1 (0.00%)  1/1 (100.00%) 
Infections and infestations             
Flu   1/1 (100.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/1 (0.00%)  0/1 (0.00%) 
Metabolism and nutrition disorders             
high glucose   0/1 (0.00%)  0/2 (0.00%)  1/2 (50.00%)  0/2 (0.00%)  0/1 (0.00%)  0/1 (0.00%) 
Musculoskeletal and connective tissue disorders             
headache/neck pain/low back pain   0/1 (0.00%)  0/2 (0.00%)  2/2 (100.00%)  0/2 (0.00%)  0/1 (0.00%)  1/1 (100.00%) 
Nervous system disorders             
Sleep disturbance   1/1 (100.00%)  1/2 (50.00%)  1/2 (50.00%)  0/2 (0.00%)  1/1 (100.00%)  1/1 (100.00%) 
Psychiatric disorders             
Anxiety   0/1 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/1 (100.00%)  0/1 (0.00%) 
Respiratory, thoracic and mediastinal disorders             
Congestion/Breathlessness/chest tightness/cough   1/1 (100.00%)  2/2 (100.00%)  1/2 (50.00%)  1/2 (50.00%)  1/1 (100.00%)  1/1 (100.00%) 
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Fernando Martinez
Organization: University of Michigan
Phone: (734) 763-2540
Publications:
Responsible Party: Umadevi S. Sajjan, University of Michigan
ClinicalTrials.gov Identifier: NCT01708278     History of Changes
Obsolete Identifiers: NCT02013440
Other Study ID Numbers: HUM00061735
R21AT007357 ( U.S. NIH Grant/Contract )
First Submitted: October 10, 2012
First Posted: October 16, 2012
Results First Submitted: October 31, 2016
Results First Posted: December 26, 2016
Last Update Posted: December 26, 2016