A novel fortified blended flour, corn-soy blend "plus-plus," is not inferior to lipid-based ready-to-use supplementary foods for the treatment of moderate acute malnutrition in Malawian children

Background: Children with moderate acute malnutrition (MAM) are often treated with fortified blended flours, most commonly a corn-soy blend (CSB). However, recovery rates remain <75%, lower than the rate achieved with peanut paste-based ready-to-use supplementary foods (RUSFs). To bridge this gap, a novel CSB recipe fortified with oil and dry skim milk, "CSB++," has been developed. Objective: In this trial we compared CSB++ with 2 RUSF products for the treatment of MAM to test the hypothesis that the recovery rate achieved with CSB++ will not be >5% worse than that achieved with either RUSF. Design: We conducted a prospective, randomized, investigatorblinded, controlled noninferiority trial involving rural Malawian children aged 6-59 mo with MAM. Children received 75 kcal CSB++ - kg ^-1 - d ^-1, locally produced soy RUSF, or an imported soy/whey RUSF for ≤12 wk. Results: The recovery rate for CSB++ (n = 763 of 888; 85.9%) was similar to that for soy RUSF (795 of 806, 87.7%; risk difference: 21.82%; 95% CI: 24.95%, 1.30%) and soy/whey RUSF (807 of 918, 87.9%; risk difference: 21.99%; 95% CI: 25.10%, 1.13%). On average, children who received CSB++ required 2 d longer to recover, and the rate of weight gain was less than that with either RUSF, although height gain was the same among all 3 foods studied. Conclusions: A novel, locally produced, fortified blended flour (CSB++) was not inferior to a locally produced soy RUSF and an imported soy/whey RUSF in facilitating recovery from MAM. The recovery rate observed for CSB++ was higher than that for any other fortified blended flour tested previously. This trial is registered at clinicaltrials. gov as NCT00998517.