Soya, maize, and sorghum-based ready-to-use therapeutic food with amino acid is as efficacious as the standard milk and peanut paste-based formulation for the treatment of severe acute malnutrition in children: a noninferiority individually randomized controlled efficacy clinical trial in Malawi [Nutritional epidemiology and public health]

Background: Development of more cost-effective ready-to-use therapeutic food (RUTF) is a global public health priority. To date, previous lower-cost recipes have been less effective than the standard peanut and milk (PM)–based RUTF, particularly in children aged <24 mo.

Objective: We aimed to compare the efficacy of the PM-RUTF to a milk-free soya, maize, and sorghum (FSMS)–RUTF enriched with crystalline amino acids without cow milk powder and a milk, soya, maize, and sorghum (MSMS)–RUTF containing 9.3% skim cow milk powder.

Design: This nonblinded, 3-arm, parallel-group, simple randomized controlled trial enrolled Malawian children with severe acute malnutrition.

Results: In intention-to-treat analyses, FSMS-RUTF showed noninferiority for recovery rates in children aged 24–59 mo (: –1.9%; 95% CI: –9.5%, 5.6%) and 6–23 mo (: –0.2%; 95% CI: –7.5%, 7.1%) compared with PM-RUTF. MSMS-RUTF also showed noninferiority for recovery rates in children aged 24–59 mo (: 0.0%; 95% CI: –7.3%, 7.4%) and 6–23 mo (: 0.6%; 95% CI: –4.3%, 5.5%). Noninferiority in recovery rates was also observed in per-protocol analyses. For length of stay in the program (time to cure), both FSMS-RUTF in children aged 24–59 mo (: 2.8 d; 95% CI: –0.8, 6.5 d) and 6–23 mo (: 3.4 d; 95% CI: –1.2, 8.0 d) and MSMS-RUTF in children aged 24–59 mo (: 0.2 d; 95% CI: –3.1, 3.6 d) and 6–23 mo (: 1.2 d; 95% CI: –3.4, 5.8 d) were not inferior to PM-RUTF. FSMS-RUTF was also significantly better than PM-RUTF at increasing hemoglobin and body iron stores in anemic children, with mean hemoglobin increases of 2.1 (95% CI: 1.6, 2.6) and 1.3 (95% CI: 0.9, 1.8) and mean body iron store increases of 2.0 (95% CI: 0.8, 3.3) and 0.1 (95% CI: –1.1, 1.3) for FSMS-RUTF and PM-RUTF, respectively.

Conclusions: FSMS-RUTF without milk is efficacious in the treatment of severe acute malnutrition in children aged 6–23 and 24–59 mo. It is also better at correcting iron deficiency anemia than PM-RUTF. This trial was registered at www.pactr.org as PACTR201505001101224.

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