Open AccessOral Glutathione and Growth in Cystic Fibrosis
Author(s) -
Bozic Molly,
Goss Christopher H.,
Tirouvanziam Rabindra M.,
Baines Arthur,
Kloster Margaret,
Antoine Liebe,
Borowitz Drucy,
Schwarzenberg Sarah Jane
Publication year - 2020
Publication title -
journal of pediatric gastroenterology and nutrition
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.206
H-Index - 131
eISSN - 1536-4801
pISSN - 0277-2116
DOI - 10.1097/mpg.0000000000002948
Subject(s) - medicine , placebo , gastroenterology , clinical endpoint , cystic fibrosis , glutathione , randomized controlled trial , multicenter trial , weight loss , obesity , pathology , multicenter study , alternative medicine , biochemistry , chemistry , enzyme
Objectives: The nutritional status of children with cystic fibrosis (CF) is associated with mortality and morbidity. Intestinal inflammation may contribute to impaired digestion, absorption, and nutrient utilization in patients with CF and oral glutathione may reduce inflammation, promoting improved nutritional status in patients with CF. Methods: The GROW study was a prospective, multicenter, randomized, placebo‐controlled, double‐blind, phase II clinical trial in pancreatic insufficient patients with CF between the ages of 2 and 10 years. Patients received reduced glutathione or placebo orally daily for 24 weeks. The primary endpoint was the difference in change in weight‐for‐age z ‐scores from baseline through week 24 between treatment groups. Secondary endpoints included other anthropometrics, serum, and fecal inflammatory markers in addition to other clinical outcomes. Results: Fifty‐eight participants completed the study. 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 (−0.08; 95% CI: −0.22 to 0.06; P = 0.25); absolute change in weight (kg) (−0.18; 95% CI: −0.55 to 0.20; P = 0.35); or absolute change in BMI kg/m 2 (−0.06; 95% CI: −0.37 to 0.25; P = 0.69). There were no significant differences in other secondary endpoints. Overall, glutathione was safe and well tolerated. Conclusions: Oral glutathione supplementation did not impact growth or change serum or fecal inflammatory markers in pancreatic insufficient children with CF when compared with placebo.