Glutathione and Health With Post-Polio Syndrome

NCT01402570 | Completed Results

• 1 other identifier: PPH-1051
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-polio Syndrome; Physical Activity; Depression; Pain; Sleep Disorders

Keywords

disability; polio; rehabilitation; wellness

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

Glutathione supplement

EXPERIMENTAL

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

Dietary Supplement: Glutathione

Interventions

Glutathione 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.

Also known as: 500 Ultrathoine, GSH and l-glutathione.

Glutathione supplement

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Having another serious medical condition (cancer, multiple sclerosis, etc.)or inflammatory disease (ie., lupus)
• Currently taking glutathione or other antioxidants

Sponsors & Collaborators

• University of Michigan: lead
• Penn State University: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48108, United States

Location

MeSH Terms

Conditions

Postpoliomyelitis Syndrome; Motor Activity; Depression; Pain; Sleep Wake Disorders; Poliomyelitis

Interventions

Glutathione

Condition Hierarchy (Ancestors)

Myelitis; Central Nervous System Infections; Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neurodegenerative Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases; Behavior; Behavioral Symptoms; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins

Limitations and Caveats

Sample size of 20 was quite small to make generalizations to the larger population. Dosing and duration of the intervention may not have been sufficient to effect change.

Results Point of Contact

• Title: Claire Z. Kalpakjian
• Organization: University of Michigan

clairez@umich.edu

734-763-0153

Study Officials

• Claire Kalpakjian, PhD, MS

  University of Michigan

  PRINCIPAL INVESTIGATOR

• Mark Ziadeh, MD

  University of Michigan

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 25, 2011
• First Posted: July 26, 2011
• Study Start: August 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: July 1, 2013
• Last Updated: February 17, 2017
• Results First Posted: February 17, 2017

Record last verified: 2016-12

Locations

US (1)