Abstract
ObjectivesThis study compared the effectiveness of 4 specialized nutritious foods (SNFs) used for the treatment of moderate acute malnutrition (MAM) in children <5 years of age in Pujehun District, Sierra Leone. MethodsThis was a cluster-randomized trial operating through a supplementary feeding program (SFP) providing SNFs for treatment of MAM. Three study foods were fortified blended foods – Super Cereal Plus w/amylase (SC + A), Corn-soy Blend Plus w/oil (CSB + w/oil), and Corn-soy-whey Blend w/oil (CSWB w/oil) – and one was a lipid-based Ready to Use Supplementary Food (RUSF). From 4/2017 to 11/2018, children with MAM, defined as mid-upper arm circumference (MUAC) ≥11.5 cm and <12.5 cm without bipedal edema, were enrolled at participating health clinics and received rations bi-weekly until they reached an outcome or for up to 12 weeks. A stratified randomization technique was used to select 28 sites and randomize them into 7 per arm based on pre-determined criteria. During the study, an 8th site was added to the CSWB w/oil arm due to low enrollment. The primary outcome was graduation from SFP defined as MUAC ≥12.5 cm within the 12-week treatment period. Mixed-effect regression assessed whether there were differences in graduation rates among children treated with one of the 4 SNFs. ResultsA total of 2683 children were enrolled out of a planned sample size of ∼5000. Overall: 63% graduated from MAM, 19% developed severe acute malnutrition (SAM), 7% defaulted (missed 3 visits in a row), 1% died, and 10% reached no outcome within 12 weeks. Twenty-five % were transferred into the study from SAM treatment. By study arm, graduation rates were: 62% in CSWB w/oil, 65% in SC + A, 64% in CSB + w/oil, 62% in RUSF. In an unadjusted model, statistically significant differences in graduation rates between the arms were not detected. Data analysis is ongoing to determine if this finding is maintained in adjusted models. ConclusionsThe 4 foods performed comparably in treating MAM in unadjusted analysis. Decision-making by donors, governments, and programmers on which food to program should also be based on cost-effectiveness analysis. Funding SourcesSupported by the Office of Food for Peace, Bureau for Democracy, Conflict, and Humanitarian Assistance, U.S. Agency for International Development.
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