Milk Fat Globule Membrane-Enhanced RUTF for Children With Severe Acute Malnutrition
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-59
SponsorWashington University School of Medicine
About this trial
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
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- MFGM-RUTF (milk fat globule membrane ready-to-use therapeutic food)
- S-RUTF (standard ready-to-use therapeutic food)
- Amoxicillin
- Sulfadoxine (12.5 mg)/Pyrimethamine (250 mg)
Treatment groups
1,600 Participants
are divided into 2 treatment groupsSponsors and collaborators
Washington University School of Medicine
Lead sponsor
Project Peanut Butter
Collaborator
Ministry of Health and Sanitation, Sierra Leone
Collaborator
Arla Foods
Collaborator
The Danish Dairy Research Foundation, Denmark
Collaborator
Source ClinicalTrials.gov