Clinical Trial: Glutathione and Health With Post-Polio Syndrome

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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.


Sponsor: University of Michigan

Current Primary Outcome:

  • 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.
  • 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.
  • 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) 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

    Original Primary Outcome: Examine the effect of oral glutathione supplementation on people with late effects of poliomyelitis on measures of fatigue, physical functioning, sleep disturbance and emotional distress. [ Time Frame: 3 months ]

    Measure function, sleep patterns and emotional distress before and after oral glutathione supplement is given.


    Current Secondary Outcome:

    Original Secondary Outcome:

    Information By: University of Michigan

    Dates:
    Date Received: July 25, 2011
    Date Started: August 2011
    Date Completion:
    Last Updated: December 22, 2016
    Last Verified: December 2016