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Recruiting NCT06869850

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

Conditions: Severe Acute Malnutrition, Cognitive Impairment, Kwashiorkor, Severe Wasting

Sex: All
Ages: 6 Months – 59 Months
Healthy volunteers: No
Phase: NA
Enrollment: 1600
Sponsor: Washington University School of Medicine

Location: Bandajuma Bandajuma Pujehun

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

Eligibility Criteria

Inclusion Criteria: * 6-59 months of age * Reside within the catchment area of a participating clinic * mid-upper arm circumference \< 11.5 cm and/or weight-for-length z-score \< -3 and/or presence of bilateral pedal pitting edema * willingness to comply with all study procedures and availability for the duration of the study, including no plan to move from the catchment area of a participating clinic Exclusion Criteria: * Features of complicated SAM: inability to tolerate a 30 g test dose of RUTF, breathing difficulties, mental status changes, sepsis, diarrhea with severe dehydration, and/or physician/nursing clinical assessment that the child needs immediate hospitalization * Participation in a separate therapeutic feeding program within the past month * Known allergy to study food ingredient (peanut, milk, fish) * Clinically evident developmental delay (most often determined based on research nursing assessment of physical appearance, movement, and informal discussion with caregiver) * Presence of a chronic severe medical condition (other than tuberculosis and HIV), such as congenital heart disease

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06869850). StuddyBuddy aggregates publicly available trial information.