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Trial · Interventional

CompletedNot applicableResults postedRegistry data

Glutathione and Health With Post-Polio Syndrome

NCTNCT01402570 (opens ClinicalTrials.gov in a new tab)Other idPPH-1051
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Not applicable
Enrollment
20 participants (actual)
Sponsor
University of Michigan · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
Aug 2011
Primary completion
Apr 2013
Completion
Jul 2013
First posted
26 Jul 2011 (estimated)
Last update posted
17 Feb 2017
Conditions
Post-polio Syndrome · Physical Activity · Depression · Pain · Sleep Disorders

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2011201220132014
  1. N/A

    Glutathione and Health With Post-Polio Syndrome

    NCT01402570

    Aug 2011 to Jul 2013

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

In this study, people who have symptoms of post polio will take oral glutathione supplements for three months. Their levels of fatigue, physical activity and sleep efficiency will be assessed.

Interventions

  • GlutathioneDietary supplement

Arms1

  • Experimental

    Glutathione supplement

    All subjects will be taking a glutathione supplement.Glutathione is a naturally occuring antioxidant and a nonessential amino acid.

Primary outcomes4

Outcomes the sponsor listed as primary.

  1. PROMIS (Patient Reported Outcomes Measurement Information System) Physical Functioning

    Time frame · Baseline, 1 month, 2 months and 3 months

    Registry 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.

  2. Sleep Efficiency

    Time frame · Baseline, 1 month, 2 months and 3 months

    Registry 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.

  3. Steps Per Day

    Time frame · Baseline, 1 month, 2 months and 3 months

    Registry description

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

  4. PROMIS (Patient Reported Outcomes Measurement Information System) Fatigue

    Time frame · Baseline, 1 month, 2 months and 3 months

    Registry 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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Baseline, 1 month, 2 months and 3 months

PROMIS (Patient Reported Outcomes Measurement Information System) Physical Functioning

GroupValue (units on a scale)Spread
Study Group37.84.6
Primary outcomeMean· Baseline, 1 month, 2 months and 3 months

Sleep Efficiency

GroupValue (units on a scale)Spread
Study Group82.114.6
Primary outcomeMean· Baseline, 1 month, 2 months and 3 months

Steps Per Day

GroupValue (steps per day)Spread
Study Group4004.13357.9
Primary outcomeMean· Baseline, 1 month, 2 months and 3 months

PROMIS (Patient Reported Outcomes Measurement Information System) Fatigue

GroupValue (units on a scale)Spread
Study Group56.08.7

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Study GroupAll 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).–0 / 201 / 20

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 50 Years up to 65 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Ability to walk 100 feet with usual assistive devices (ex. cane or walker) * Having a function score of 18-32 when tested with the IPPS (Index of Post- Polio Sequelae). This will include people with post-polio symptoms in a very specific range of severity. Exclusion Criteria: * Having another serious medical condition (cancer, multiple sclerosis, etc.)or inflammatory disease (ie., lupus) * Currently taking glutathione or other antioxidants

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