Glutathione and Health With Post-Polio Syndrome

University of Michigan20 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Post-polio Syndrome Physical Activity Depression Pain Sleep Disorders

Interventions

GlutathioneDIETARY_SUPPLEMENT

glutathione is a dietary supplement and an antioxidant. Subjects will take 1000 mg per day for three month. Each capsule contains 500 mg glutathione.

Eligibility

Sex: ALLMin age: 50 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Michigan

Ann Arbor, Michigan, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Baseline, 1 month, 2 months and 3 months

Steps Per Day

Count of steps per day using activity monitor worn on upper arm.

Time frame: 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.

Time frame: Baseline, 1 month, 2 months and 3 months

Data from ClinicalTrials.gov

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