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

PLoS One. 2021 Oct 28;16(10):e0258715. doi: 10.1371/journal.pone.0258715. eCollection 2021.

Abstract

Background: 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+.

Methods and findings: 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.

Conclusions: 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.

Trial registration: Pan-African Clinical Trial Registration number: PACTR201809662822990.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Child, Preschool
  • Equivalence Trials as Topic
  • Ethiopia / epidemiology
  • Female
  • Food, Fortified / analysis*
  • Glycine max / chemistry*
  • Humans
  • Infant
  • Infant Nutritional Physiological Phenomena
  • Male
  • Malnutrition / diet therapy*
  • Malnutrition / epidemiology
  • Zea mays / chemistry*

Grants and funding

The author who received the award of this study is Debritu Nane (corresponding author). The grant number of the award is ETH-13/0025. The funding organization of this research is NORAD (Norwegian Agency for Development Cooperation); through the NORHED program (Norwegian Program for Capacity Development in Higher Education and Research for Development). URL of the funder is “South Ethiopia Network of Universities in Public Health (SENUPH) improving women’s participation in post graduate education”. This funding organization is responsible in the process of designing the study and data collection, analysis, and interpretation and in writing the manuscript.