Glutathione and Health With Post-Polio Syndrome

NCT ID: NCT01402570

Last Updated: 2017-02-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2013-07-31

Brief Summary

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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 Description

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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.

Conditions

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Post-polio Syndrome Physical Activity Depression Pain Sleep Disorders

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Glutathione supplement

All subjects will be taking a glutathione supplement.Glutathione is a naturally occuring antioxidant and a nonessential amino acid.

Group Type EXPERIMENTAL

Glutathione

Intervention Type 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.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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500 Ultrathoine, GSH and l-glutathione.

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Penn State University

OTHER

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Claire Z. Kalpakjian

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Claire Kalpakjian, PhD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Mark Ziadeh, MD

Role: STUDY_CHAIR

University of Michigan

Locations

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University of Michigan

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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PPH-1051

Identifier Type: -

Identifier Source: org_study_id

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