Oral Glutathione and Growth in Cystic Fibrosis: A Multicenter, Randomized, Placebo-controlled, Double-blind Trial. Issue 6 (December 2020)

• Record Type: Journal Article
• Authors: Bozic, Molly; Goss, Christopher H.; Tirouvanziam, Rabindra M.; Baines, Arthur; Kloster, Margaret; Antoine, Liebe; Borowitz, Drucy; Schwarzenberg, Sarah Jane
• Is Part Of: Journal of pediatric gastroenterology and nutrition. Volume 71:Issue 6(2020)
• Publication Date: 2020-12
• Subjects: antioxidant -- calprotectin -- inflammation; Children -- Nutrition -- Periodicals; Pediatric gastroenterology -- Periodicals; Infants -- Nutrition -- Periodicals; Nutrition disorders in children -- Periodicals; Child Nutrition -- Periodicals; Digestive System -- growth & development -- Periodicals; Gastrointestinal Diseases -- Periodicals; Infant Nutrition -- Periodicals; Nutrition Disorders -- Periodicals; Child; 618.923
• DOI: 10.1097/MPG.0000000000002948
• Languages: English
• ISSNs: 0277-2116

Abstract

ABSTRACT: 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. Abstract : Supplemental Digital Content is available in the text