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Glutathione and Health With Post-Polio Syndrome

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01402570
First Posted: July 26, 2011
Last Update Posted: February 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Penn State University
Information provided by (Responsible Party):
Claire Z. Kalpakjian, University of Michigan
  Purpose
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.

Condition Intervention
Post-polio Syndrome Physical Activity Depression Pain Sleep Disorders Dietary Supplement: Glutathione

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Oral Glutathione and Health Outcomes Among Persons With Post-Polio Syndrome

Resource links provided by NLM:


Further study details as provided by Claire Z. Kalpakjian, University of Michigan:

Primary Outcome Measures:
  • 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.

  • 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.

  • 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.

  • 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.


Enrollment: 20
Study Start Date: August 2011
Study Completion Date: July 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Glutathione supplement
All subjects will be taking a glutathione supplement.Glutathione is a naturally occuring antioxidant and a nonessential amino acid.
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.
Other Name: 500 Ultrathoine, GSH and l-glutathione.

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01402570


Locations
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48108
Sponsors and Collaborators
University of Michigan
Penn State University
Investigators
Principal Investigator: Claire Kalpakjian, PhD, MS University of Michigan
Study Chair: Mark Ziadeh, MD University of Michigan
  More Information

Responsible Party: Claire Z. Kalpakjian, Assistant Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT01402570     History of Changes
Other Study ID Numbers: PPH-1051
First Submitted: July 25, 2011
First Posted: July 26, 2011
Results First Submitted: January 22, 2016
Results First Posted: February 17, 2017
Last Update Posted: February 17, 2017
Last Verified: December 2016

Keywords provided by Claire Z. Kalpakjian, University of Michigan:
disability
polio
rehabilitation
wellness

Additional relevant MeSH terms:
Syndrome
Sleep Wake Disorders
Parasomnias
Poliomyelitis
Postpoliomyelitis Syndrome
Disease
Pathologic Processes
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Myelitis
Central Nervous System Infections
Central Nervous System Diseases
Spinal Cord Diseases
Neuromuscular Diseases
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Neurodegenerative Diseases