Cereals and pulse-based ready-to-use therapeutic food as an alternative to the standard milk- and peanut paste-based formulation for treating severe acute malnutrition: a noninferiority, individually randomized controlled efficacy clinical trial

BACKGROUND: The cost of current standard ready-to-use therapeutic food (RUTF) is among the major obstacles to scaling up community-based management of acute malnutrition (CMAM), an important child survival strategy. Identifying a cheaper alternative is a global public health priority. OBJECTIVE: We sought to compare the efficacy of soya-maize-sorghum RUTF (SMS-RUTF) with that of standard peanut paste-based RUTF (P-RUTF). DESIGN: We used a nonblinded, parallel-group, simple randomized controlled trial along with a day care approach that enrolled 2 groups of children aged 6-23 and 24-59 mo, respectively, with severe acute malnutrition (SAM). RESULTS: Intention-to-treat (ITT) and per-protocol (PP) analyses showed noninferiority of SMS-RUTF compared with P-RUTF for the recovery rate [ITT: Δ = -2.0% (95% CI: -7.6%, 3.6%); PP: -1.9% (95% CI: -5.3%, 1.4%)], weight gain [Δ = -0.7 g · kg(-1)· d(-1)(95% CI: -1.3, 0.0 g · kg(-1)· d(-1))], and length of stay [Δ = 2.0 d (95% CI: -1.7, 5.8 d)] in children ≥24 mo of age. In children ≤23 mo of age, the recovery rate of SMS-RUTF was inferior to that of P-RUTF [ITT: Δ = -20.8% (95% CI: -29.9%, -11.7%); PP: -17.2% (95% CI: -25.6%, -8.7%)]. Treatment with SMS-RUTF resulted in a greater increase in hemoglobin [0.670 g/dL (95% CI: 0.420, 0.921 g/dL);P< 0.001]. Treatment with both RUTFs resulted in the replenishment of all of the amino acids tested except for methionine. There were no differences at discharge between RUTF groups in fat mass [Δ = 0.3 kg (95% CI: -0.6, 1.6 kg);P= 0.341] or fat mass index [Δ = 0.4 kg/m(2)(95% CI: -0.3, 1.1 kg/m(2));P= 0.262]. By contrast, comparisons of fat-free mass indicated lower concentrations than the community controls after treatment with either of the 2 RUTFs [Δ = -1.3 kg (95% CI: -2.4, -0.1 kg) andP= 0.034 for comparison between community controls and the SMS-RUTF group; Δ = -1.8 kg (95% CI: -2.9, -0.6 kg) andP= 0.003 for comparison between community controls and the P-RUTF group]. CONCLUSION: SMS-RUTF can be used to treat SAM in children aged ≥24 mo to reduce the costs of CMAM programs. More research is required to optimize SMS-RUTF for younger children. This trial was registered in the Pan African Clinical Trial Registry as PACTR201303000475166.