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Clinical trialNCT06869850RecruitingInterventional

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

SponsorWashington University School of MedicineEnrollment1,600Cognitive ImpairmentKwashiorkorSevere Acute MalnutritionSevere Wasting
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

10 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Sierra Leone
  • Bandajuma

    Bandajuma, Pujehun, Sierra Leone

    Recruiting
  • Bandasuma

    Bandasuma, Pujehun, Sierra Leone

    Recruiting
  • Bendu Malen

    Bendu Malen, Pujehun, Sierra Leone

    Recruiting
  • Gbondapi

    Gbondapi, Pujehun, Sierra Leone

    Recruiting
  • Jendema

    Jendema, Pujehun, Sierra Leone

    Recruiting
  • Potoru

    Potoru, Pujehun, Sierra Leone

    Recruiting
  • Sahn Malen

    Sahn Malen, Pujehun, Sierra Leone

    Recruiting
  • Taninahun

    Taninahun, Pujehun, Sierra Leone

    Recruiting
  • Zimmi

    Zimmi, Pujehun, Sierra Leone

    Recruiting
  • Static

    Pujehun, Sierra Leone

    Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

AmoxicillinSulfadoxine
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
22 Sept 2025
Primary completion
1 Dec 2027
Completion
1 Dec 2027
Last update posted
17 Dec 2025
Registered enrollment
1,600
Registry id
NCT06869850

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.