Yael Lebenthal1, Michal Yackobovitch-Gavan2, Liora Lazar1, Shlomit Shalitin1, Ariel Tenenbaum2, Raanan Shamir3, Moshe Phillip4. 1. The Jesse Z and Sara Lea Shafer Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel, Petah Tikva, Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel. 2. The Jesse Z and Sara Lea Shafer Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel, Petah Tikva, Israel. 3. Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel; Institute for Gastroenterology, Nutrition, and Liver Diseases, Schneider Children's Medical Center of Israel, Petah Tikva, Israel. 4. The Jesse Z and Sara Lea Shafer Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel, Petah Tikva, Israel; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel. Electronic address: mosheph@post.tau.ac.il.
Abstract
OBJECTIVE: To determine the effect of nutritional supplementation on height, weight, and body mass index (BMI) in short and lean prepubertal children. STUDY DESIGN: A prospective, randomized, double-blinded, placebo-controlled trial of nutritional supplementation at the endocrinology department of a tertiary pediatric medical center of healthy, lean, short, prepubertal children 3-9-years-old. Anthropometry measurements were measured at 6 months. RESULTS:Two hundred participants (149 boys) entered the study and 171 (85.5%) completed the intervention period. Baseline characteristics including age, sex, height-SDS, weight-SDS, BMI-SDS, and dietary caloric and protein intakes were similar in the formula and placebo groups. 'Good' consumers (intake of ≥50% of the recommended dose) in the formula group significantly improved height-SDS (P < .001) and weight-SDS (P = .005) with no change in BMI-SDS compared with 'poor' consumers and the placebo group. In the formula-treated group a positive correlation was found between the amount of formula consumed per body weight and the gain in height-SDS (r = 0.44, P < .001) and weight-SDS (r = 0.35, P = .002); no significant correlations were found in the placebo group. No serious adverse events were reported during the study. CONCLUSIONS: Nutritional intervention with the formula was found to be a feasible, effective, and safe approach for promoting the physical growth of short and lean prepubertal children.
RCT Entities:
OBJECTIVE: To determine the effect of nutritional supplementation on height, weight, and body mass index (BMI) in short and lean prepubertal children. STUDY DESIGN: A prospective, randomized, double-blinded, placebo-controlled trial of nutritional supplementation at the endocrinology department of a tertiary pediatric medical center of healthy, lean, short, prepubertal children 3-9-years-old. Anthropometry measurements were measured at 6 months. RESULTS: Two hundred participants (149 boys) entered the study and 171 (85.5%) completed the intervention period. Baseline characteristics including age, sex, height-SDS, weight-SDS, BMI-SDS, and dietary caloric and protein intakes were similar in the formula and placebo groups. 'Good' consumers (intake of ≥50% of the recommended dose) in the formula group significantly improved height-SDS (P < .001) and weight-SDS (P = .005) with no change in BMI-SDS compared with 'poor' consumers and the placebo group. In the formula-treated group a positive correlation was found between the amount of formula consumed per body weight and the gain in height-SDS (r = 0.44, P < .001) and weight-SDS (r = 0.35, P = .002); no significant correlations were found in the placebo group. No serious adverse events were reported during the study. CONCLUSIONS: Nutritional intervention with the formula was found to be a feasible, effective, and safe approach for promoting the physical growth of short and lean prepubertal children.
Authors: Apurba K Ghosh; Bala Kishore; Irfan Shaikh; Vinita Satyavrat; Anil Kumar; Tapan Shah; Prahlad Pote; Sandeep Shinde; Yatin Berde; Yen Ling Low; Verena M H Tan; Dieu T T Huynh Journal: J Int Med Res Date: 2018-04-25 Impact factor: 1.671