Optimizing management of uncomplicated acute malnutrition in children in rural Niger: a 3-arm individually randomized, controlled, noninferiority trial

The Optimizing treatment for acute MAlnutrition (OptiMA) and Combined Protocol for Acute Malnutrition Study (ComPAS) strategies aim to simplify acute malnutrition treatment programs by treating severe and moderate cases with one product—ready-to-use therapeutic food (RUTF)—at gradually reduced doses.

This individually randomized controlled trial (NCT04698070) was conducted in Niger between 2021 and 2022 to evaluate the noninferiority of OptiMA and ComPAS compared with Niger’s standard national protocol in children aged 6–59 months. Eligible participants had a mid-upper arm circumference (MUAC) <125 mm or edema. The primary outcome was defined as being alive, not acutely malnourished (MUAC ≥125 mm, weight-for-height z-score ≥−3, and no edema), and without relapse over a 6-month period.

Among 1,732 children with acute malnutrition, noninferiority was demonstrated for ComPAS (51.9%, difference 1.0% [97.5% CI: –5.5%, +7.6%]) and OptiMA (49.7%, difference 3.2% [–3.3%, +9.9%]) in the intention-to-treat analysis, but only for ComPAS in per-protocol analysis. Among 1,140 children with MUAC <115 mm or edema, the standard protocol achieved higher nutritional recovery, although mortality did not differ across arms. Growth trajectories were similar between Standard and ComPAS, which used 50% less RUTF, but lower for OptiMA, which used 32% less RUTF.

Overall, only the ComPAS protocol demonstrated noninferiority to standard treatment. Reducing RUTF dosage did not negatively affect survival or growth. Further research is needed to assess the acceptability and population-level impact of simplified treatment protocols across diverse settings.

See the project page here.