High-protein Quantity and Quality RUTF in Improving Linear Growth Among Children With Severe Wasting

This is a proof-of-concept trial that aims to compare the efficacy of an 8-week treatment with higher-protein-Ready-to-Use Therapeutic Foods (RUTF) with standard RUTF in improving levels of markers of growths, height, nutritional recovery, and lean mass deposition among children with severe wasting. The study will also assess the safety and acceptability of the high-protein RUTF in comparison to the standard RUTF. The study will be conducted at four outpatient therapeutic programs in the Blantyre district of Malawi.

Inclusion Criteria:Infants 6-23 months of age with severe wasting at OTP admission according to the WHO criteria: WHZ below -3 or MUAC below 115mm.Parent or guardian is able and available to consentChildren who are able to feed orally in the usual state of healthThe primary caregiver plans to stay in the study area during the duration of the study.Exclusion Criteria:Children with medical complications as per the CMAM guidelines (lack of appetite, severe oedematous malnutrition, acute infections)mild and moderate nutritional oedemaChildren with a known terminal illness (e.g. cancer), cerebral palsy (CP), tuberculosis (TB,) HIV infected or exposedChildren who had SAM in the last 8 weeks, i.e., SAM relapses in the last 8 weeksChildren admitted to any NRU due to complicated SAM in the previous 4 weeks will also be excludedChildren whose caregivers refuse to give consent or whose primary givers are not available to give consentChildren who were previously enrolled in this trial or currently enrolled in this trial whose sibling has also been enrolled in the studyChildren with known intolerance or allergy to high protein diets will be excluded as well as known intolerance or allergy to milk/lactose