Milk Fat Globule Membrane-Enhanced RUTF for Children With Severe Acute Malnutrition
Status:
RECRUITING
Trial end date:
2027-12-01
Target enrollment:
Participant gender:
Summary
The goal of this clinical trial is to test the use of milk fat globule membrane (MFGM) in ready-to-use therapeutic food (RUTF) in children with severe acute malnutrition in Sierra Leone. The main questions it aims to answer are:
* Will the inclusion of MFGM in RUTF for 6-59-month-old Sierra Leonean children with severe acute malnutrition improve their neurodevelopment?
* Will the inclusion of MFGM in RUTF for 6-59-month-old Sierra Leonean children with severe acute malnutrition reduce its worst consequences: death, hospitalization, and remaining severely malnourished despite treatment?
Researchers will compare the MFGM-containing RUTF to standard RUTF, which contains skim milk powder.
Participants will:
* undergo measurement of length, weight, mid-upper arm circumference, and nutritional edema assessment every two weeks during severe malnutrition treatment
* be treated with either MFGM-RUTF or standard RUTF at a dose of 2 sachets per day for up to 12 weeks
* undergo neurodevelopmental testing using the Malawi Developmental Assessment Tool at the end of SAM treatment and 6 months later
* a subset of participants will undergo blood spot collection and stool sample collection
Phase:
NA
Details
Lead Sponsor:
Washington University School of Medicine
Collaborators:
Arla Food Ingredients Group P/S Ministry of Health and Sanitation, Sierra Leone Project Peanut Butter The Danish Dairy Research Foundation, Denmark