Glutathione and Health With Post-Polio Syndrome

Study Overview
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Brief Summary
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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.

Detailed Description
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Subjects will take a glutathione supplement by mouth for three months after an initial medical visit, blood draw and physical exam. There are four timepoints during the three months when subjects will fill out surveys and record food intake and sleep times in diaries for seven days. They will also wear a small device for seven days, a Sensewear monitor that records physical activity, body temperature and other measures. After the fourth timepoint they will return to the medical center for another physical exam and blood draw. Physicians trained in physical medicine and rehabilitation will be monitoring the study.

Official Title
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Oral Glutathione and Health Outcomes Among Persons With Post-Polio Syndrome

Conditions
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Post-polio Syndrome, Physical Activity, Depression, Pain, Sleep Disorders

Intervention / Treatment
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* Dietary Supplement: Glutathione


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Glutathione supplement<br>All subjects will be taking a glutathione supplement.Glutathione is a naturally occuring antioxidant and a nonessential amino acid. | Dietary Supplement: Glutathione<br>* glutathione is a dietary supplement and an antioxidant. Subjects will take 1000 mg per day for three month. Each capsule contains 500 mg glutathione.<br>* Other names: 500 Ultrathoine, GSH and l-glutathione.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PROMIS (Patient Reported Outcomes Measurement Information System) Physical Functioning | 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. | Baseline, 1 month, 2 months and 3 months | 
| Sleep Efficiency | 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. | Baseline, 1 month, 2 months and 3 months | 
| Steps Per Day | Count of steps per day using activity monitor worn on upper arm. | Baseline, 1 month, 2 months and 3 months | 
| PROMIS (Patient Reported Outcomes Measurement Information System) Fatigue | 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. | Baseline, 1 month, 2 months and 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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disability, polio, rehabilitation, wellness