Effect of a nutritional supplement on growth in short and lean prepubertal children: a prospective, randomized, double-blind, placebo-controlled study

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.

Trial registration: ClinicalTrials.gov NCT01158352.