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Glutathione and Health With Post-Polio Syndrome

This study is currently recruiting participants.
Verified June 2012 by University of Michigan
Sponsor:
Collaborator:
Penn State University
Information provided by (Responsible Party):
Claire Z. Kalpakjian, University of Michigan
ClinicalTrials.gov Identifier:
NCT01402570
First received: July 25, 2011
Last updated: June 8, 2012
Last verified: June 2012
History of Changes
  Purpose

In this study, people who have symptoms of post polio will take oral glutathione supplements for three months. Their levels of fatigue, physical function, sleep disturbance, impairment and emotional distress will be measured with both subjective and objective measures.


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

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Oral Glutathione and Health Outcomes Among Persons With Post-Polio Syndrome

Resource links provided by NLM:

Drug Information available for: Glutathione
U.S. FDA Resources

Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Examine the effect of oral glutathione supplementation on people with late effects of poliomyelitis on measures of fatigue, physical functioning, sleep disturbance and emotional distress. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    In this study, the subject's function, sleep patterns and emotional distress before and after taking a glutathione supplement.


Estimated Enrollment: 20
Study Start Date: August 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: September 2012 (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

Ages Eligible for Study:   50 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01402570

Contacts
Contact: Connie Pines 734 764-1454 canewman@umich.edu
Contact: Kathleen Donnelly kldonnel@umich.edu

Locations
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48108
Principal Investigator: Claire Z. Kalpakjian, MS, PhD            
Sponsors and Collaborators
University of Michigan
Penn State University
  More Information

No publications provided

Responsible Party: Claire Z. Kalpakjian, Assistant Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT01402570     History of Changes
Other Study ID Numbers: PPH-1051
Study First Received: July 25, 2011
Last Updated: June 8, 2012
Health Authority: United States: Federal Government

Keywords provided by University of Michigan:
disability
polio
rehabilitation
wellness

Additional relevant MeSH terms:
Poliomyelitis
Depression
Depressive Disorder
Sleep Disorders
Parasomnias
Postpoliomyelitis Syndrome
Behavioral Symptoms
Mood Disorders
Mental Disorders
Myelitis
Central Nervous System Viral Diseases
Virus Diseases
Enterovirus Infections
 Picornaviridae Infections
RNA Virus Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Neuromuscular Diseases
Neurologic Manifestations
Signs and Symptoms
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on May 19, 2013