Glutathione and Health With Post-Polio Syndrome

Oral Glutathione and Health Outcomes Among Persons 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.

Study Overview

• Status: Completed
• Conditions: Depression; Pain; Physical Activity; Sleep Disorders; Post-polio Syndrome
• Intervention / Treatment: Dietary supplement: 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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48108
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 500 Ultrathoine, GSH and l-glutathione.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, 1 month, 2 months and 3 months
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.	Baseline, 1 month, 2 months and 3 months
Steps Per Day	Count of steps per day using activity monitor worn on upper arm.	Baseline, 1 month, 2 months and 3 months
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.	Baseline, 1 month, 2 months and 3 months

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: Penn State University
• Investigators: Principal Investigator: Claire Kalpakjian, PhD, MS, University of Michigan; Study Chair: Mark Ziadeh, MD, University of Michigan

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: July 25, 2011
• First Submitted That Met QC Criteria: July 25, 2011
• First Posted (Estimate): July 26, 2011

Study Record Updates

• Last Update Posted (Actual): February 17, 2017
• Last Update Submitted That Met QC Criteria: December 22, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: rehabilitation; disability; polio; wellness
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Central Nervous System Diseases; Nervous System Diseases; RNA Virus Infections; Virus Diseases; Infections; Neurologic Manifestations; Disease; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Central Nervous System Infections; Neurodegenerative Diseases; Enterovirus Infections; Picornaviridae Infections; Spinal Cord Diseases; Muscular Disorders, Atrophic; Myelitis; Syndrome; Sleep Wake Disorders; Poliomyelitis; Postpoliomyelitis Syndrome
• Other Study ID Numbers: PPH-1051