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Glutathione and Health With Post-Polio Syndrome

Primary Purpose

Post-polio Syndrome, Physical Activity, Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Glutathione
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-polio Syndrome focused on measuring disability, polio, rehabilitation, wellness

Eligibility Criteria

50 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Michigan

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Glutathione supplement

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 25, 2011
Last Updated
December 22, 2016
Sponsor
University of Michigan
Collaborators
Penn State University
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1. Study Identification

Unique Protocol Identification Number
NCT01402570
Brief Title
Glutathione and Health With Post-Polio Syndrome
Official Title
Oral Glutathione and Health Outcomes Among Persons With Post-Polio Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
Penn State University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-polio Syndrome, Physical Activity, Depression, Pain, Sleep Disorders
Keywords
disability, polio, rehabilitation, wellness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Glutathione supplement
Arm Type
Experimental
Arm Description
All subjects will be taking a glutathione supplement.Glutathione is a naturally occuring antioxidant and a nonessential amino acid.
Intervention Type
Dietary Supplement
Intervention Name(s)
Glutathione
Other Intervention Name(s)
500 Ultrathoine, GSH and l-glutathione.
Intervention Description
glutathione is a dietary supplement and an antioxidant. Subjects will take 1000 mg per day for three month. Each capsule contains 500 mg glutathione.
Primary Outcome Measure Information:
Title
PROMIS (Patient Reported Outcomes Measurement Information System) Physical Functioning
Description
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
Title
Sleep Efficiency
Description
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
Title
Steps Per Day
Description
Count of steps per day using activity monitor worn on upper arm.
Time Frame
Baseline, 1 month, 2 months and 3 months
Title
PROMIS (Patient Reported Outcomes Measurement Information System) Fatigue
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claire Kalpakjian, PhD, MS
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mark Ziadeh, MD
Organizational Affiliation
University of Michigan
Official's Role
Study Chair
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48108
Country
United States

12. IPD Sharing Statement

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Glutathione and Health With Post-Polio Syndrome

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