Simplifying and optimising management of acute malnutrition in children aged 6 to 59 months: study protocol for a 3 arms community-based individually randomised controlled trial in decentralised Niger

Over the past five years, simplified approaches to treating acute malnutrition (AM) have been developed to unify treatment processes and reach more children aged 6 to 59 months without medical complications. Two of these approaches - Optimising Treatment for Acute Malnutrition (OptiMA) and the Combined Protocol for Acute Malnutrition Study (ComPAS) - use mid-upper arm circumference (MUAC) as the main admission and discharge criterion. Both treat children with MUAC below 125 mm or oedema using a single product, ready-to-use therapeutic food (RUTF), provided in gradually tapered doses.
The OptiMA Niger trial compared these two simplified strategies with Niger’s standard national nutrition protocol. The study assessed outcomes at six months after enrolment, focusing on favourable recovery rates among children with uncomplicated acute malnutrition, including those with severe malnutrition (MUAC below 115 mm or oedema).
Conducted from March 2021 in the Zinder region of Niger, the individually randomised, non-inferiority clinical trial involved children aged 6–59 months attending primary health centres or identified through community screening. All participants were followed for six months. The study evaluated whether reducing RUTF dosage based on MUAC (ComPAS) or MUAC and weight (OptiMA) could maintain recovery and survival outcomes equivalent to Niger’s standard protocol.
By generating robust evidence on simplified and optimised approaches to treating acute malnutrition, this trial contributes to global efforts to build consensus on how best to expand effective, efficient, and equitable nutrition care for children in humanitarian and low-resource settings.
Please see the study page here.