Comparison of the effectiveness of a milk‐free soy‐maize‐sorghum‐based ready‐to‐use therapeutic food to standard ready‐to‐use therapeutic food with 25% milk in nutrition management of severely acutely malnourished Z ambian children: an equivalence non‐blinded cluster randomised controlled trial

C ommunity‐based M anagement of A cute M alnutrition using r eady‐to‐ u se t herapeutic f ood ( RUTF ) has revolutionised the treatment of severe acute malnutrition ( SAM ). However, 25% milk content in standard peanut‐based RUTF ( P ‐RUTF) makes it too expensive. The effectiveness of milk‐free RUTF has not been reported hitherto. This non‐blinded, parallel group, cluster randomised, controlled, equivalence trial that compares the effectiveness of a milk‐free soy–maize–sorghum‐based RUTF ( SMS ‐ RUTF ) with P ‐RUTF in treatment of children with SAM , closes the gap. A statistician randomly assigned health centres ( HC ) either to the SMS ‐ RUTF ( n  = 12; 824 enrolled) or P ‐ RUTF ( n  = 12; 1103 enrolled) arms. All SAM children admitted at the participating HC s were enrolled. All the outcomes were measured at individual level. Recovery rate was the primary outcome. The recovery rates for SMS ‐ RUTF and P ‐ RUTF were 53.3% and 60.8% for the intention‐to‐treat ( ITT ) analysis and 77.9% and 81.8% for per protocol ( PP ) analyses, respectively. The corresponding adjusted risk difference ( ARD ) and 95% confidence interval, were −7.6% (−14.9, 0.6%) and −3.5% (−9,6., 2.7%) for ITT ( P  = 0.034) and PP analyses ( P  = 0.257), respectively. An unanticipated interaction (interaction P  < 0.001 for ITT analyses and 0.0683 for PP analyses) between the study arm and age group was observed. The ARD s were −10.0 (−17.7 to −2.3)% for ITT ( P  = 0.013) and −4.7 (−10.0 to 0.7) for PP ( P  = 0.083) analyses for the <24 months age group and 2.1 (−10.3,14.6)% for ITT ( P  = 0.726) and −0.6 (−16.1, 14.5) for PP ( P  = 0.939) for the ≥24 months age group. In conclusion, the study did not confirm our hypothesis of equivalence between SMS ‐ RUTF and P ‐ RUTF in SAM management.