Safety, Efficacy, and Cost-effectiveness of Modified Doses of Ready-to-Use Therapeutic and Supplementary Foods for Treating Moderate Acute Malnutrition in Children 6-59 Months

What this Trial Is About

Researchers are studying new simplified treatment approaches for moderate acute malnutrition (MAM) in children aged 6 to 59 months. The study aims to evaluate two modified dosage regimens of ready-to-use therapeutic food (RUTF) compared to the current standard dosage of ready-to-use supplementary food (RUSF). This research addresses challenges in current community-based management of acute malnutrition that has seen little change in over 20 years and seeks to improve program coverage for malnourished children. The trial randomly assigns participants to one of three groups receiving either the standard RUSF dose (1 sachet daily providing 535 kcal), a lower dose of RUTF (1 sachet daily providing 500 kcal), or a higher dose of RUTF (2 sachets daily providing 1000 kcal). These dietary supplements are given for up to 16 weeks to monitor recovery and nutritional status. The study includes double-blind masking to compare safety, efficacy, and cost-effectiveness of these modified doses. Participants will be assessed weekly during treatment for weight gain, mid-upper-arm circumference changes, height growth, and body composition via bioelectrical impedance analysis. Immunological function, rates of acute illness, hospitalization, mortality, and treatment duration are also monitored weekly. After recovery, medium-term outcomes such as relapse rates and nutritional gains will be evaluated for up to six months. The study aims to measure short- and medium-term nutritional recovery and cost efficiency among the treatment groups.

Modified Dosage for Moderate Acute Malnutrition (MODAM-MAM)