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.

<h4>Background</h4>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...

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Autores principales:	Debritu Nane, Anne Hatløy, Bernt Lindtjørn
Formato:	article
Lenguaje:	EN
Publicado:	Public Library of Science (PLoS) 2021
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/28cf010b49024e4dab3701ce552c8340
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spelling	oai:doaj.org-article:28cf010b49024e4dab3701ce552c83402021-12-02T20:16:31ZA 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.1932-620310.1371/journal.pone.0258715https://doaj.org/article/28cf010b49024e4dab3701ce552c83402021-01-01T00:00:00Zhttps://doi.org/10.1371/journal.pone.0258715https://doaj.org/toc/1932-6203<h4>Background</h4>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+.<h4>Methods and findings</h4>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.<h4>Conclusions</h4>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.<h4>Trial registration</h4>Pan-African Clinical Trial Registration number: PACTR201809662822990.Debritu NaneAnne HatløyBernt LindtjørnPublic Library of Science (PLoS)articleMedicineRScienceQENPLoS ONE, Vol 16, Iss 10, p e0258715 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Debritu Nane Anne Hatløy Bernt Lindtjørn 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.
description	<h4>Background</h4>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+.<h4>Methods and findings</h4>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.<h4>Conclusions</h4>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.<h4>Trial registration</h4>Pan-African Clinical Trial Registration number: PACTR201809662822990.
format	article
author	Debritu Nane Anne Hatløy Bernt Lindtjørn
author_facet	Debritu Nane Anne Hatløy Bernt Lindtjørn
author_sort	Debritu Nane
title	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.
title_short	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.
title_full	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.
title_fullStr	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.
title_full_unstemmed	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.
title_sort	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.
publisher	Public Library of Science (PLoS)
publishDate	2021
url	https://doaj.org/article/28cf010b49024e4dab3701ce552c8340
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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.

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