Supplementation of Oral Reduced Glutathione in Pediatric Cystic Fibrosis Patients

What Was Tested

This registered not phased trial tested Glutathione.

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.

It had two arms (groups): one (experimental) and Placebo Calcium Citrate (placebo comparator).

The registry classes the interventions as dietary supplement.

More on the Plan

Cystic fibrosis (CF) is known principally for its pulmonary consequences.

However, for most individuals with CF, the earliest manifestations are not pulmonary, but gastro-intestinal.

Many children experience growth failure.

Chronic gut inflammation also develops.

Who Took Part

47 actual participants took part.

It was open to people of any sex aged from 18 months up to 10 years.

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

Examples of who could join: Diagnosis of Cystic Fibrosis by either of the following criteria: \>60 sweat chloride test or paired deleterious DNA cystic fibrosis transmembrane conductance regulator (CFTR) mutations (Ambry genetics, Genetech or ARUP);. Pancreatic insufficient as defined by doctor's prescription of pancreatic enzymes.

The full record lists 2 inclusion and 4 exclusion criteria; among the exclusions: hospitalized for bowel obstruction or surgery in the six months prior to enrollment;; had had a pulmonary exacerbation or oral steroid use or iv antibiotics within one month of enrollment,; who had been taking either gsh or n-acetyl cysteine (nac) within the 12 month period immediately prior to the trial,.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

Because people in this Glutathione study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Glutathione group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Glutathione.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2011-03 with completion listed for 2012-03.

It ran at 1 site in Italy.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Weight Percentile at 3 Months (time frame: 3 months). Height Percentile (time frame: 3 months). BMI Percentile (time frame: 3 months).

It also tracked 32 secondary outcomes, for example Forced Vital Capacity, FEV1, Bacteriology, Forced Vital Capacity, FEV1 and C-Reactive Protein (CRP).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Glutathione in 47 people.

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.