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Trial record 6 of 580 for:    reduced glutathione

Glutathione and Health With Post-Polio Syndrome

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: NCT01402570
Recruitment Status : Completed
First Posted : July 26, 2011
Results First Posted : February 17, 2017
Last Update Posted : February 17, 2017
Sponsor:
Collaborator:
Penn State University
Information provided by (Responsible Party):
Claire Z. Kalpakjian, University of Michigan

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Post-polio Syndrome
Physical Activity
Depression
Pain
Sleep Disorders
Intervention Dietary Supplement: Glutathione
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Study Group
Hide Arm/Group Description All subjects took a three month trials of 1,000 mg of glutathione supplement
Period Title: Overall Study
Started 20
Completed 19
Not Completed 1
Reason Not Completed
Adverse Event             1
Arm/Group Title Study Group
Hide Arm/Group Description All subjects were assigned the intervention. The intervention was a three-month trial of twice daily, oral, 1,000 mg glutathione supplements (Glutathione 500 Ultrathione, The Glutathione Corporation, Elmsford, New York; 500 mg. capsule with 250 mg. ascorbic acid).
Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
The target population for this study was individuals between the ages of 50 and 65 who self-reported symptoms consistent with post-polio syndrome and able to ambulate 100 feet without assistive devices.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants
60.85  (3.89)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
9
  45.0%
Male
11
  55.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
2
  10.0%
White
18
  90.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants
20
PROMIS Physical Functioning   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 20 participants
37.8  (4.6)
[1]
Measure Description: Assesses the ability to carry out activities that require physical actions, ranging from self-care (activities of daily living) to more complex activities that require a combination of skills, often within a social context. Scores are standardized T-scores with mean of 50 and standard deviation of 10; higher scores indicate better physical function.
Subjective sleep efficiency   [1] 
Mean (Standard Deviation)
Unit of measure:  Percentage
Number Analyzed 20 participants
82.0  (14.6)
[1]
Measure Description: Sleep efficiency is defined as the ratio of time sleeping and time in bed. Using a sleep diary, participants recorded bedtime the night before, amount of time it took to fall asleep, number and total duration of awakenings, time of final awakening, and time of rising. Efficiency ranges from 0 to 100; higher values indicate higher sleep efficiency or more time sleeping when in bed.
PROMIS Fatigue   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 20 participants
56.0  (8.7)
[1]
Measure Description: Assesses fatigue from mild subjective feelings to an overwhelming, debilitating, and sustained sense of exhaustion that is likely to decrease one’s ability to carry out daily activities, including the ability to work effectively and to function at one’s usual level in family or social roles. Fatigue is divided conceptually into the experience of fatigue (e.g., frequency, duration, and intensity), and the impact of fatigue upon physical, mental and social activities.Scores are standardized T-scores with mean of 50 and standard deviation of 10; higher scores indicate greater fatigue.
Physical activity, number of steps daily   [1] 
Mean (Standard Deviation)
Unit of measure:  Steps/day
Number Analyzed 20 participants
4004.1  (3357.9)
[1]
Measure Description: Refers to cumulative steps per day (24 hours period). 10,000 or more steps per day is considered optimal.
1.Primary Outcome
Title PROMIS (Patient Reported Outcomes Measurement Information System) Physical Functioning
Hide Description Ability to carry out activities that require physical actions, ranging from self-care (activities of daily living) to more complex activities that require a combination of skills, often within a social context. Scores are standardized T-scores with mean of 50 and standard deviation of 10; higher scores indicate better physical function.
Time Frame Baseline, 1 month, 2 months and 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Group
Hide Arm/Group Description:
All subjects were assigned the intervention. The intervention was a three-month trial of twice daily, oral, 1,000 mg glutathione supplements (Glutathione 500 Ultrathione, The Glutathione Corporation, Elmsford, New York; 500 mg. capsule with 250 mg. ascorbic acid).
Overall Number of Participants Analyzed 19
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 37.8  (4.6)
1 month 37.9  (4.3)
2 months 37.5  (5.6)
3 months 38.1  (5.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Study Group
Comments Linear mixed modeling (LMM) with random effects for intercept and repeated effects for assessment period was used to analyze change over time for study outcomes. The primary predictor of interest in this study was the relationship of time to each of the outcomes to evaluate the potential effect of the intervention. Independent LMMs were used to study outcomes.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.66
Comments Time was predictor of interest, controlling for age, gender, baseline PROMIS physical functioning, and overall functional status.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter REML
Estimated Value 0.17
Confidence Interval (2-Sided) 95%
-0.67 to 0.95
Estimation Comments [Not Specified]
2.Primary Outcome
Title Sleep Efficiency
Hide Description The ratio of time asleep over time in bed gathered from sleep diaries completed at bedtime and at awakening. Scores range from 0 to 100%, higher values indicate better sleep efficiency or more time sleeping in bed.
Time Frame Baseline, 1 month, 2 months and 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Group
Hide Arm/Group Description:
All subjects took a three month trials of 1,000 mg of glutathione supplement
Overall Number of Participants Analyzed 19
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 82.1  (14.6)
1 month 86.9  (9.2)
2 months 87.6  (8.4)
3 months 87.8  (8.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Study Group
Comments Linear mixed modeling (LMM) with random effects for intercept and repeated effects for assessment period was used to analyze change over time for study outcomes. The primary predictor of interest in this study was the relationship of time to each of the outcomes to evaluate the potential effect of the intervention. Independent LMMs were used to study outcomes.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.44
Comments Time was predictor of interest, controlling for age, gender, baseline sleep efficiency, and overall functional status.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter REML
Estimated Value 0.00
Confidence Interval (2-Sided) 95%
-0.01 to 0.02
Estimation Comments [Not Specified]
3.Primary Outcome
Title Steps Per Day
Hide Description Count of steps per day using activity monitor worn on upper arm.
Time Frame Baseline, 1 month, 2 months and 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Group
Hide Arm/Group Description:
All subjects were assigned the intervention. The intervention was a three-month trial of twice daily, oral, 1,000 mg glutathione supplements (Glutathione 500 Ultrathione, The Glutathione Corporation, Elmsford, New York; 500 mg. capsule with 250 mg. ascorbic acid).
Overall Number of Participants Analyzed 19
Mean (Standard Deviation)
Unit of Measure: steps per day
Baseline 4004.1  (3357.9)
1 month 3590.7  (2928.3)
2 months 3598.9  (3139.3)
3 months 3693.1  (3317.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Study Group
Comments Linear mixed modeling (LMM) with random effects for intercept and repeated effects for assessment period was used to analyze change over time for study outcomes. The primary predictor of interest in this study was the relationship of time to each of the outcomes to evaluate the potential effect of the intervention. Independent LMMs were used to study outcomes.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.35
Comments Time was predictor of interest, controlling for age, gender, baseline steps per day, and overall functional status.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter REML
Estimated Value 145.54
Confidence Interval (2-Sided) 95%
-178.93 to 470.02
Estimation Comments [Not Specified]
4.Primary Outcome
Title PROMIS (Patient Reported Outcomes Measurement Information System) Fatigue
Hide Description Assesses fatigue from mild subjective feelings to an overwhelming, debilitating, and sustained sense of exhaustion that is likely to decrease one’s ability to carry out daily activities, including the ability to work effectively and to function at one’s usual level in family or social roles. Fatigue is divided conceptually into the experience of fatigue (e.g., frequency, duration, and intensity), and the impact of fatigue upon physical, mental and social activities. Scores are on a T-metric with mean of 50 and standard deviation of 10; higher scores indicate greater fatigue.
Time Frame Baseline, 1 month, 2 months and 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Study Group
Hide Arm/Group Description:
All subjects were assigned the intervention. The intervention was a three-month trial of twice daily, oral, 1,000 mg glutathione supplements (Glutathione 500 Ultrathione, The Glutathione Corporation, Elmsford, New York; 500 mg. capsule with 250 mg. ascorbic acid).
Overall Number of Participants Analyzed 19
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 56.0  (8.7)
1 month 54.9  (7.1)
2 months 53.4  (9.2)
3 months 52.8  (9.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Study Group
Comments Linear mixed modeling (LMM) with random effects for intercept and repeated effects for assessment period was used to analyze change over time for study outcomes. The primary predictor of interest in this study was the relationship of time to each of the outcomes to evaluate the potential effect of the intervention. Independent LMMs were used to study outcomes.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.07
Comments Time was predictor of interest, controlling for age, gender, baseline fatigue, and overall functional status.
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter REML
Estimated Value -1.05
Confidence Interval (2-Sided) 95%
-2.21 to 0.10
Estimation Comments [Not Specified]
Time Frame Entire study period of three months - baseline to the end of the trial.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Study Group
Hide Arm/Group Description All subjects were assigned the intervention. The intervention was a three-month trial of twice daily, oral, 1,000 mg glutathione supplements (Glutathione 500 Ultrathione, The Glutathione Corporation, Elmsford, New York; 500 mg. capsule with 250 mg. ascorbic acid).
All-Cause Mortality
Study Group
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Study Group
Affected / at Risk (%) # Events
Total   0/20 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Study Group
Affected / at Risk (%) # Events
Total   1/20 (5.00%)    
Skin and subcutaneous tissue disorders   
allergic reaction *  1/20 (5.00%)  1
*
Indicates events were collected by non-systematic assessment
Sample size of 20 was quite small to make generalizations to the larger population. Dosing and duration of the intervention may not have been sufficient to effect change.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Claire Z. Kalpakjian
Organization: University of Michigan
Phone: 734-763-0153
Responsible Party: Claire Z. Kalpakjian, University of Michigan
ClinicalTrials.gov Identifier: NCT01402570     History of Changes
Other Study ID Numbers: PPH-1051
First Submitted: July 25, 2011
First Posted: July 26, 2011
Results First Submitted: January 22, 2016
Results First Posted: February 17, 2017
Last Update Posted: February 17, 2017