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

RecruitingNAAges 6 Months - 59 MonthsAllWashington University School of Medicine
NCT06869850 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 MF

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📋 Eligibility rules (as published)
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
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What it tests

  • MFGM-RUTF (milk fat globule membrane ready-to-use therapeutic food)
  • S-RUTF (standard ready-to-use therapeutic food)
  • Amoxicillin
  • Sulfadoxine (250 mg)/Pyrimethamine (12.5 mg)
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Where

10 sites
Bandajuma
Bandajuma, Sierra Leone
Bandasuma
Bandasuma, Sierra Leone
Bendu Malen
Bendu Malen, Sierra Leone
Gbondapi
Gbondapi, Sierra Leone
Jendema
Jendema, Sierra Leone
Potoru
Potoru, Sierra Leone
Static
Pujehun, Sierra Leone
Sahn Malen
Sahn Malen, Sierra Leone

…and 2 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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