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

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.

Fig 1. Flowchart of study enrollment to completion.

Screened for MAM, children aged 6 to 59 months who screened for moderate acute malnutrition; Children without MAM, children aged 6 to 59 months who did not have moderate acute malnutrition; Randomized children aged 6 to 59 months who were assessed positive for moderate acute malnutrition, fulfilled the inclusion criteria, were recruited and randomly allocated; The loss to follow-up, children who were randomly allocated to intervention and control groups and stopped participating in the study at any stage of the study; Discontinued due to SAM, children who were randomly allocated to intervention and control groups and discontinued from the study at any stage of the study; Analyzed at 12 weeks, children aged 6 to 59 months whose information was analyzed at 12 weeks; ITT and PP analysis are done. Abbreviations: MAM: moderate acute malnutrition; LIBS: local-ingredients-based supplement; CSB+: corn-soy blend plus; SAM: severe acute malnutrition; ITT: intention to treat; PP: per-protocol.

Fig 2. Difference in recovery rate between LIBS and CSB+ groups.

The recovery rate in the LIBS group was non-inferior compared with the CSB+ group. Numbers are risk differences in recovery rates between groups (%). The dotted line indicates the predefined non-inferiority margin. Abbreviations: LIBS: local-ingredients-based supplement; CSB+: corn-soy blend plus; PP: per-protocol; ITT: intention to treat.

Fig 3. Difference in average weight gain (g/kg/day) between LIBS and CSB+ groups.

The average daily weight gain in the LIBS group was non-inferior compared with the CSB+ group. Numbers are risk differences in average weight gains between groups (g/kg/day). The dotted line indicates the predefined non-inferiority margin. Abbreviations: LIBS: local-ingredients-based supplement; CSB+: corn-soy blend plus; PP: per-protocol; ITT: intention-to-treat. The generalized estimating equation was used.

Fig 4. Difference in recovery time in days between LIBS and CSB+ groups.

The recovery time in the LIBS group was non-inferior compared with the CSB+ group. Numbers are risk differences of recovery time in days between groups. The dotted line indicates the predefined non-inferiority margin. Abbreviations: LIBS: local-ingredients-based supplement; CSB+: corn-soy blend plus; PP: per-protocol; ITT: intention to treat. The generalized estimating equation was used.

Fig 5. Recovery of children with moderate acute malnutrition over time in the LIBS and CSB+ arms in ITT analysis.

The recovery of children with MAM over time in the LIBS group was similar to the CSB+ group. Survival analysis, Kaplan-Meier curves and Log-rank tests were used to analyze and describe the data. Abbreviations: MAM: moderate acute malnutrition; LIBS: local-ingredients-based supplement; CSB+: corn-soy blend plus; ITT: intention to treat.

Fig 6. Recovery of children with moderate acute malnutrition over time in the LIBS and CSB+ arms in PP analysis.

The recovery of children with MAM over time in the LIBS group was similar to the CSB+ group. Survival analysis, Kaplan-Meier curves, and Log-rank tests were used to analyze and describe the data. Abbreviations: MAM: moderate acute malnutrition; LIBS: local-ingredients-based supplement; CSB+: corn-soy blend plus; PP: per-protocol.