Testing Milk Fat Globule Membrane in Ready-to-Use Therapeutic Food for Children 6-59 Months with Severe Acute Malnutrition in Sierra Leone to Improve Brain Development and Survival

What this Trial Is About

Researchers are evaluating a new formulation of ready-to-use therapeutic food RUTF that includes milk fat globule membrane MFGM to treat children aged 6 to 59 months with severe acute malnutrition SAM in Sierra Leone. The study aims to find out if MFGM-enhanced RUTF can improve neurodevelopment and reduce serious outcomes like death, hospitalization, or remaining severely malnourished compared to standard RUTF containing skim milk powder. This trial is a randomized, blinded, controlled clinical study involving 1600 children across 20 rural sites. Participants will be assigned to receive either MFGM-RUTF or standard RUTF, with both groups consuming 2 sachets daily for up to 12 weeks. Each sachet contains about 92 grams of therapeutic food providing roughly 1000 calories, protein, fat, and micronutrients. Along with RUTF, some children may receive medications such as amoxicillin and malaria chemoprophylaxis as part of their treatment. The treatment period includes fortnightly clinic visits for measurements and assessments. During the study, children will have their length, weight, arm circumference, and nutritional edema measured every two weeks while receiving treatment. Neurodevelopment will be assessed using the Malawi Developmental Assessment Tool MDAT at the end of treatment and again 6 months later. A subset of participants will provide blood and stool samples. Researchers will measure outcomes including neurodevelopment scores, survival, hospitalization, and nutritional recovery over periods ranging from 2 weeks to 7 months after treatment.

Milk Fat Globule Membrane-Enhanced RUTF for Children With Severe Acute Malnutrition