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Completed

NCT Number: NCT01402570

Glutathione and Health With Post-Polio Syndrome

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.

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Key information

Conditions

Post-Polio Syndrome Behavior Behavioral Symptoms Central Nervous System Diseases Central Nervous System Infections Depression Enterovirus Infections Infections Mental Disorders Motor Activity Muscular Diseases Muscular Disorders, Atrophic Musculoskeletal Diseases Myelitis Nervous System Diseases Neurodegenerative Diseases Neuroinflammatory Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Physical Activity Picornaviridae Infections Poliomyelitis Postpoliomyelitis Syndrome RNA Virus Infections Signs and Symptoms Sleep Disorders Sleep Wake Disorders Spinal Cord Diseases Virus Diseases

Age range

50 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48108, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glutathione

Dietary 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.

Other names: 500 Ultrathoine, GSH and l-glutathione.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Penn State University

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jul 26, 2011
Registry last updated
Feb 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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