Journal Article

A local-ingredients-based supplement is an alternative to corn-soy blends plus for treating moderate acute malnutrition among children aged 6 to 59 months: A randomized controlled non-inferiority trial in Wolaita, Southern Ethiopia

Lindtjørn, Bernt, Nane, Debritu, Hatløy, Anne

2021

Overview

Globally, moderate acute malnutrition (MAM) affects approximately 5% of children below five years of age. MAM is a persistent public health problem in Ethiopia. The current approach in Ethiopia for managing MAM is a supplementary feeding program; however, this is only provided to chronically food-insecure areas. The objective of the study was to compare a local-ingredients-based supplement (LIBS) with the standard corn-soy blend plus (CSB+) in treating MAM among children aged 6 to 59 months to test the hypothesis that the recovery rate achieved with LIBS will not be more than 7% worse than that achieved with CSB+. We used an individual randomized controlled non-inferiority trial design with two arms, involving 324 children with MAM aged 6 to 59 months in Wolaita, Southern Ethiopia. One hundred and sixty-two children were randomly assigned to each of the two arms. In the first arm, 125.2 g of LIBS with 8 ml of refined deodorized and cholesterol-free sunflower oil/day was provided. In the second arm, 150 g of CSB+ with 16 ml of refined deodorized and cholesterol-free sunflower oil/day was provided. Each child was provided with a daily ration of either LIBS or CSB+ for 12 weeks. Both intention-to-treat (ITT) and per-protocol (PP) analyses were done. ITT and PP analyses showed non-inferiority of LIBS compared with CSB+ for recovery rate [ITT risk difference = 4.9% (95% CI: -4.70, 14.50); PP risk difference = 3.7% (95% CI: -5.91, 13.31)]; average weight gain [ITT risk difference = 0.10 g (95% CI: -0.33 g, 0.53 g); PP risk difference = 0.04 g (95% CI: -0.38 g, 0.47 g)]; and recovery time [ITT risk difference = -2.64 days (95% CI: -8.40 days, 3.13 days); PP difference -2.17 days (95% CI: -7.97 days, 3.64 days]. Non-inferiority in MUAC gain and length/height gain was also observed in the LIBS group compared with the CSB+ group. LIBS can be used as an alternative to the standard CSB+ for the treatment of MAM. Thus, the potential of scaling up the use of LIBS should be promoted. Pan-African Clinical Trial Registration number: PACTR201809662822990.

• Publisher: Public Library of Science,Public Library of Science (PLoS)
• Subject: Anthropometry / Biology and Life Sciences / Body measurements / Body weight gain / Care and treatment / Caregivers / Child, Preschool / Children / Children & youth / Cholesterol / Composition / Consent / Corn / Diet / Dietary supplements / Edema / Environmental health / Equivalence Trials as Topic / Ethiopia - epidemiology / Female / Food / Food, Fortified - analysis / Glycine max - chemistry / Health aspects / Helianthus / Humans / Infant / Infant Nutritional Physiological Phenomena / Ingredients / Male / Malnutrition / Malnutrition - diet therapy / Malnutrition - epidemiology / Medicine and Health Sciences / People and Places / Physiological aspects / Public health / Recovery time / Risk / Sunflower oil / Sunflowers / Vegetable oils / Zea mays - chemistry