A six-month randomized controlled pilot study evaluating the effects of an oral nutrition supplement on children's growth patterns

Q3 Nursing

Clinical Nutrition Open Science Pub Date : 2025-02-01 DOI:10.1016/j.nutos.2024.11.006

Robert Frument , Ceci Mao , Becca Li , Clara Chan , Diana Pozo , John Ademola , Michael Milobsky

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Abstract

Background and aims

Pilot study to evaluate the effect of oral nutrition supplementation (ONS) among children and adolescents.

Methods

A prospective, randomized trial of nutritional supplementation was conducted among 32 children and adolescents 4–17 years of age. Change in height and weight standard deviation score (SDS) as well as measures of body composition were measured 3 times over a six month study period. Participants in the treatment arm were given ONS to take once a day, 5 days a week; the controls continued their usual diet. Three study visits were conducted to collect measurements for all subjects: baseline, 3 months and 6 months. Univariate, bivariate and multivariate analyses were conducted to estimate the effect of the powder supplement on height velocity as measured by standard deviation score (SDS) as well as static body composition measurements (lean body mass, fat-free mass, body mass index (BMI)) and collagen X concentration in the urine.

Results

The mean change in height SDS increased in both the treatment and control groups, but only the treatment group achieved statistical significance (SDS 0.09, 95% Confidence Interval (CI) 0.04, 0.15, p=0.0028). The mean increase in height in the treatment group was 2.94 cm (95% CI 2.22, 3.66) compared to 2.23 cm (95% CI 1.34, 3.12) in the control group. Changes in the secondary outcome measures (BMI, fat mass, lean mass and collagen X) did not reach statistical significance. The most parsimonious linear regression model (p<0.0001, Adj R-squared 0.6950) suggests that the ONS afforded a 0.281 cm growth advantage when controlling for baseline age, sex, height, and collagen X.

Conclusions

The change in height SDS was statistically significant only in the treatment group (p=0.0028). While both groups grew, as expected, the multivariate model suggests an advantage for the treatment group when controlling for baseline characteristics.