Safety, Efficacy, and Cost-effectiveness of Modified Doses of Ready-to-use Therapeutic Food for Severe Acute Malnutrition in Children 6-59 Months in Ethiopia

What this Trial Is About

Researchers are evaluating two simplified dosing methods of Ready-to-Use Therapeutic Food (RUTF) for treating severe acute malnutrition (SAM) in children aged 6 to 59 months. The study aims to improve program coverage by testing fixed-dose regimens against the current weight-based dosing approach. This research is conducted by Action Against Hunger USA to address longstanding challenges in managing acute malnutrition with complex protocols and supply issues. The trial includes three groups: one receiving standard weight-based RUTF dosing at 150-200 kcal/kg/day, another given two sachets (1000 kcal) of RUTF daily, and a third group receiving two sachets daily while severely malnourished, then reducing to one sachet as the child's condition improves. Amoxicillin is also given following Ethiopian national guidelines. The study is randomized, double-blinded, and runs for up to 16 weeks, focusing on nutritional recovery and cost-effectiveness. Participants will be monitored weekly for weight, mid-upper arm circumference (MUAC), height, body composition via bioelectrical impedance, and immune function through blood tests. Researchers will track illness rates, mortality, hospitalization, and treatment duration during the trial and assess medium-term outcomes up to six months post-recovery. The study measures both short-term recovery from SAM and longer-term nutritional status and relapse rates, with safety and cost-efficiency also evaluated throughout.

Modified Dosage for Severe Acute Malnutrition