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

NCT03020719 ↗

Phase 2 Completed 60 enrolled University of Minnesota Cystic Fibrosis Foundation · collab

RandomizedParallel-groupTriple-blindSupportive care

Summary

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.

Timeline

Start: 2017-06-14
Primary completion: 2018-12-12
Completion: 2018-12-12

Outcome

Missed primary endpoint

registry analysis (superiority test); Oral Glutathione vs Placebo; p = 0.2521; Mean Difference (Final Values) -0.081 (95% CI -0.221 to 0.059); Mixed Models Analysis NCT03020719 ↗

paper No significant differences were seen between glutathione (n = 30) and placebo (n = 28) groups in the 6-month change in weight-for-age z-score PMID 32960827 ↗

Publications

Bozic M, Goss CH, Tirouvanziam RM, Baines A, Kloster M, Antoine L, Borowitz D, Schwarzenberg SJ; GROW study group. Oral Glutathione and Growth in Cystic Fibrosis: A Multicenter, Randomized, Placebo-controlled, Double-blind Trial. J Pediatr Gastroenterol Nutr. 2020 Dec;71(6):771-777. doi: 10.1097/MPG.0000000000002948.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Glutathione	Peptide	65 mg/kg	Oral