Efficacy of long-term oral nutritional supplementation with dietary counseling on growth, body composition and bone mineralization in children with or at risk for undernutrition: a randomized controlled trial
Abstract
Background: Impaired growth, accompanied by low lean mass and poor bone mineralization in undernourished children, is linked to adverse short- and long-term health outcomes. Oral nutritional supplements (ONS) promote catch-up growth, but their efficacy in improving lean mass and bone mineralization remains uninvestigated. This study aims to compare the efficacy of long-term ONS with dietary counseling (DC) versus DC alone on growth, body composition, bone mineralization, and health outcomes in children with or at risk of undernutrition.
Methods: Children (n = 330) aged 24-60 months with WHO Growth Standard z-scores of weight-for-age < - 1, height-for-age < - 1, and weight-for-height < 0 were randomized in a multisite controlled trial to receive two servings of a complete and balanced ONS formula with DC, or DC-only, for 240 days. Anthropometric measurements, dietary intake, and parent-reported measures of illness-related and other health outcomes were assessed at baseline and days 30, 120, and 240. Dual X-ray absorptiometry-assessed body composition and bone mineralization, and nutritional blood biomarkers were measured at baseline and day 240.
Results: ONS supplementation augmented growth in height and weight through day 240, with increasing between-group differences over visits (P < 0.01 for treatment-by-visit interaction in height, weight, height-for-age and weight-for-age z-scores). Energy and protein intake levels were 26% and 22% higher, respectively, in the ONS + DC…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 330 participants or records.
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