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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01402570
Other study ID # PPH-1051
Secondary ID
Status Completed
Phase N/A
First received July 25, 2011
Last updated August 20, 2013
Start date August 2011
Est. completion date July 2013

Study information

Verified date August 2013
Source University of Michigan
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

In this study, people who have symptoms of post polio will take oral glutathione supplements for three months. Their levels of fatigue, physical function, sleep disturbance, impairment and emotional distress will be measured with both subjective and objective measures.


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.


Recruitment information / eligibility

Status Completed
Enrollment 19
Est. completion date July 2013
Est. primary completion date April 2013
Accepts healthy volunteers No
Gender Both
Age group 50 Years to 65 Years
Eligibility 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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

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.

Locations

Country Name City State
United States University of Michigan Ann Arbor Michigan

Sponsors (2)

Lead Sponsor Collaborator
University of Michigan Penn State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. In this study, the subject's function, sleep patterns and emotional distress before and after taking a glutathione supplement. 3 months No
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