Oral Glutathione and Health Outcomes Among Persons With Post-Polio Syndrome
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Michigan
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Sleep Efficiency
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Sleep Efficiency
Time Frame: 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.
PROMIS (Patient Reported Outcomes Measurement Information System) Fatigue
Time Frame: 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.
Steps Per Day
Time Frame: Baseline, 1 month, 2 months and 3 months
Count of steps per day using activity monitor worn on upper arm.
PROMIS (Patient Reported Outcomes Measurement Information System) Physical Functioning
Time Frame: Baseline, 1 month, 2 months and 3 months
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Claire Z. Kalpakjian
Assistant Professor
University of Michigan