Glutathione and Health With Post-Polio Syndrome

What Was Tested

The trial (not phased) is built around Glutathione.

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.

It had 1 arm (groups): Glutathione supplement (experimental).

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

The registry classes the interventions as dietary supplement.

More on the Plan

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.

Who Took Part

20 actual participants took part.

It was open to people of any sex aged from 50 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 2 inclusion and 2 exclusion criteria; among the exclusions: having another serious medical condition (cancer, multiple sclerosis, etc.)or inflammatory disease (ie., lupus); currently taking glutathione or other antioxidants.

How the Study Was Run

It was run as a single-group and open-label study.

Being open-label, the Glutathione study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2011-08 with completion listed for 2013-04.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): PROMIS (Patient Reported Outcomes Measurement Information System) Physical Functioning (time frame: Baseline, 1 month, 2 months and 3 months). Sleep Efficiency (time frame: Baseline, 1 month, 2 months and 3 months). Steps Per Day (time frame: Baseline, 1 month, 2 months and 3 months).

What This Means in Plain Language

Put simply, this is a not phased trial of Glutathione in 20 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Glutathione compound page, all human trials.