CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 47 enrolled
Drug / intervention
Oral reduced l-glutathione +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02029521
NCT02029521N/ACompleted

Supplementation of Oral Reduced Glutathione in Pediatric Cystic Fibrosis for Growth Failure

Clark Bishop·interventional·Posted Jan 8, 2014·Updated Feb 8, 2016

In Brief

A clinical study evaluating Oral reduced l-glutathione and Placebo for Cystic Fibrosis. Completed, enrolled 47 participants across 1 site.

Detailed Summary

Many individuals with cystic fibrosis experience growth failure. The reasons are not clear, but inflammation of the gut in these patients seems to be one important reason. Glutathione is important to normal function of the intestine and lungs. Glutathione functions to decrease inflammation and to thin mucus. However, in cystic fibrosis, glutathione gets trapped inside of cells, so it cannot travel to the surface of the cells and perform its proper function. Moreover, glutathione has been shown to improve nutritional status in patients with AIDS and cancer. Investigators hypothesize that supplementation of oral glutathione to pediatric individuals with cystic fibrosis could improve growth failure.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
CountriesItaly
Collaborators--

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJan 8, 2014
Enrollment StartMar 1, 2011
Primary CompletionMar 1, 2012
Study CompletionJul 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 12.5 years ago

Interventions

Oral reduced l-glutathionedietary

The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.

Placebodietary

calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.