Glutathione and Health With Post-Polio Syndrome
|ClinicalTrials.gov Identifier: NCT01402570|
Recruitment Status : Completed
First Posted : July 26, 2011
Results First Posted : February 17, 2017
Last Update Posted : February 17, 2017
|Condition or disease||Intervention/treatment||Phase|
|Post-polio Syndrome Physical Activity Depression Pain Sleep Disorders||Dietary Supplement: Glutathione||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Oral Glutathione and Health Outcomes Among Persons With Post-Polio Syndrome|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||April 2013|
|Actual Study Completion Date :||July 2013|
Experimental: Glutathione supplement
All subjects will be taking a glutathione supplement.Glutathione is a naturally occuring antioxidant and a nonessential amino acid.
Dietary Supplement: Glutathione
glutathione is a dietary supplement and an antioxidant. Subjects will take 1000 mg per day for three month. Each capsule contains 500 mg glutathione.
Other Name: 500 Ultrathoine, GSH and l-glutathione.
- 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 mean of 50 and standard deviation of 10; higher scores indicate greater fatigue.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01402570
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48108|
|Principal Investigator:||Claire Kalpakjian, PhD, MS||University of Michigan|
|Study Chair:||Mark Ziadeh, MD||University of Michigan|