Glutathione and Health With Post-Polio Syndrome

Depression Clinical Trial

Official title:

Oral Glutathione and Health Outcomes Among Persons With Post-Polio Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01402570
• Other study ID #: PPH-1051
• Status: Completed
• Phase: N/A
• First received: July 25, 2011
• Last updated: August 20, 2013
• Start date: August 2011
• Est. completion date: July 2013

Study information

• Verified date: August 2013
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: July 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 65 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Pain
• Parasomnias
• Physical Activity
• Poliomyelitis
• Post-polio Syndrome
• Postpoliomyelitis Syndrome
• Sleep Disorders
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Penn State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	In this study, the subject's function, sleep patterns and emotional distress before and after taking a glutathione supplement.	3 months	No