Trial Outcomes & Findings for Glutathione and Health With Post-Polio Syndrome (NCT NCT01402570)

Last Updated: 2017-02-17

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

20 participants

Primary outcome timeframe

Baseline, 1 month, 2 months and 3 months

Results posted on

2017-02-17

Participant Flow

Participant milestones

Participant milestones
Measure	Study Group All subjects took a three month trials of 1,000 mg of glutathione supplement
Overall Study STARTED	20
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Study Group All subjects took a three month trials of 1,000 mg of glutathione supplement
Overall Study Adverse Event	1

Baseline Characteristics

Glutathione and Health With Post-Polio Syndrome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Study Group n=20 Participants 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).
Age, Continuous	60.85 years STANDARD_DEVIATION 3.89 • n=5 Participants
Gender Female	9 Participants n=5 Participants
Gender Male	11 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants
PROMIS Physical Functioning	37.8 units on a scale STANDARD_DEVIATION 4.6 • n=5 Participants
Subjective sleep efficiency	82.0 percentage STANDARD_DEVIATION 14.6 • n=5 Participants
PROMIS Fatigue	56.0 units on a scale STANDARD_DEVIATION 8.7 • n=5 Participants
Physical activity, number of steps daily	4004.1 steps/day STANDARD_DEVIATION 3357.9 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 1 month, 2 months and 3 months

Outcome measures

Outcome measures
Measure	Study Group n=19 Participants 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).
PROMIS (Patient Reported Outcomes Measurement Information System) Physical Functioning Baseline	37.8 units on a scale Standard Deviation 4.6
PROMIS (Patient Reported Outcomes Measurement Information System) Physical Functioning 1 month	37.9 units on a scale Standard Deviation 4.3
PROMIS (Patient Reported Outcomes Measurement Information System) Physical Functioning 2 months	37.5 units on a scale Standard Deviation 5.6
PROMIS (Patient Reported Outcomes Measurement Information System) Physical Functioning 3 months	38.1 units on a scale Standard Deviation 5.1

PRIMARY outcome

Timeframe: Baseline, 1 month, 2 months and 3 months

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.

Outcome measures

Outcome measures
Measure	Study Group n=19 Participants 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).
Sleep Efficiency Baseline	82.1 units on a scale Standard Deviation 14.6
Sleep Efficiency 1 month	86.9 units on a scale Standard Deviation 9.2
Sleep Efficiency 2 months	87.6 units on a scale Standard Deviation 8.4
Sleep Efficiency 3 months	87.8 units on a scale Standard Deviation 8.2

PRIMARY outcome

Timeframe: Baseline, 1 month, 2 months and 3 months

Count of steps per day using activity monitor worn on upper arm.

Outcome measures

Outcome measures
Measure	Study Group n=19 Participants 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).
Steps Per Day Baseline	4004.1 steps per day Standard Deviation 3357.9
Steps Per Day 1 month	3590.7 steps per day Standard Deviation 2928.3
Steps Per Day 2 months	3598.9 steps per day Standard Deviation 3139.3
Steps Per Day 3 months	3693.1 steps per day Standard Deviation 3317.8

PRIMARY outcome

Timeframe: Baseline, 1 month, 2 months and 3 months

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.

Outcome measures

Outcome measures
Measure	Study Group n=19 Participants 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).
PROMIS (Patient Reported Outcomes Measurement Information System) Fatigue Baseline	56.0 units on a scale Standard Deviation 8.7
PROMIS (Patient Reported Outcomes Measurement Information System) Fatigue 1 month	54.9 units on a scale Standard Deviation 7.1
PROMIS (Patient Reported Outcomes Measurement Information System) Fatigue 2 months	53.4 units on a scale Standard Deviation 9.2
PROMIS (Patient Reported Outcomes Measurement Information System) Fatigue 3 months	52.8 units on a scale Standard Deviation 9.8

Adverse Events

Study Group

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Study Group n=20 participants at risk 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).
Skin and subcutaneous tissue disorders allergic reaction	5.0% 1/20 • Number of events 1 • Entire study period of three months - baseline to the end of the trial.

Additional Information

Claire Z. Kalpakjian

University of Michigan

Phone: 734-763-0153

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place