The Role of Oral Glutathione on Growth Parameters in Children With Cystic Fibrosis

What Was Tested

In this phase 2 trial, researchers set out to test Glutathione.

The purpose of this randomized, placebo-controlled (Phase II) study will be to further evaluate the effects of oral glutathione on growth in children with CF.

It had two arms (groups): Oral Glutathione (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

A prospective, multi-center, randomized, placebocontrolled, double-blind, Phase II clinical trial.

Each subject will be seen for four study visits: Visit 1 (Screening), Visit 2 (Baseline/Randomization, Day 0), Visit 3 (Week 12) and Visit 4 (Week 24).

At Visit 2, subjects will be randomized to receive either active treatment or placebo.

Safety and clinical outcomes will be assessed throughout the study.

Who Took Part

The registry lists 60 actual participants took part.

It was open to people of any sex aged from 2 years up to 11 years.

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

Examples of who could join: Male or female ≥ 2 and \< 11 years of age at Visit 1. Weight-for-age between the 10th and 50th percentiles at Screening (Visit 1) (using the Center for Disease Control (CDC) reference equations). Current chronic use, greater than 8 weeks before Day 0, of pancreatic enzyme replacement therapy (PERT) for management of pancreatic insufficiency. Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability to comply with the requirements of the study.

The full record lists 6 inclusion and 1 exclusion criteria.

How the Study Was Run

It was run as a randomized, parallel-group and triple-blind study.

Random assignment meant chance, not the researchers, decided who got Glutathione and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on Glutathione, so expectations could not easily colour the readings.

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

It started in 2017-06-14 with completion listed for 2018-12-12.

It ran at 18 sites in United States (18).

Its stated primary purpose is supportive care.

What Was Measured

Primary outcome: Change in Weight-for-age Z-score (time frame: Baseline to 24 weeks).

It also tracked 6 secondary outcomes, for example Change in Height-for-age Z-score, Change in BMI-for-age Z-score, Change in Fecal Calprotectin, Change in High-sensitivity C-reactive Protein (Hs-CRP), Adverse Events (AEs) and Serious Adverse Events (SAEs) and Rate of Adverse Events (AEs) and Serious Adverse Events (SAEs).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Glutathione in 60 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.