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

NCT06869850 | Recruiting

• 1 other identifier: 202503015
• Study Type: interventional
• Target: 1,600
• Locations: 1 country
• Sites: 10

Brief 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

Conditions

Kwashiorkor; Severe Acute Malnutrition; Cognitive Impairment; Severe Wasting

Keywords

severe acute malnutrition; severe wasting; kwashiorkor; milk fat globule membrane; neurodevelopment; phospholipids; ganglioside; dairy fat; malawi developmental assessment tool; Sierra Leone; ready-to-use therapeutic food

Outcome Measures

Primary Outcomes (2)

• Malawi Developmental Assessment Tool global z-score

  Age-standardized score, -6 to +6, higher scores are better

  6 (5-7) months after SAM treatment completion

• Composite of poor severe acute malnutrition treatment outcomes

  This composite outcome will include death, hospitalization, and remaining severely malnourished despite 12 weeks of treatment

  2-12 weeks of therapeutic feeding

Secondary Outcomes (22)

• Malawi Developmental Assessment Tool gross motor domain z-score

  6 (5-7) months after SAM treatment completion

• Malawi Developmental Assessment Tool fine motor domain z-score

  6 (5-7) months after SAM treatment completion

• Malawi Developmental Assessment Tool language domain z-score

  6 (5-7) months after SAM treatment completion

• Malawi Developmental Assessment Tool social-emotional domain z-score

  6 (5-7) months after SAM treatment completion

• Remaining severely malnourished at end of SAM treatment

  12 weeks of therapeutic feeding

Other Outcomes (3)

• Malawi Developmental Assessment Tool global z-score in sub-groups

  6 (5-7) months after SAM outcome

• Malawi Developmental Assessment Tool global z-score in sub-groups

  Within 1 month of SAM treatment completion

• Composite of poor severe acute malnutrition treatment outcomes

  2-12 weeks of therapeutic feeding

Study Arms (2)

MFGM-RUTF (Milk fat globule membrane ready-to-use therapeutic food)

EXPERIMENTAL

One sachet contains 92g of MFGM-RUTF. During SAM treatment, each participant will be given sufficient MFGM-RUTF to consume 2 sachets per day, which will provide approximately 1000 calories, 27g of protein, 63g of fat, and over 1 RDA of micronutrients.

Dietary Supplement: MFGM-RUTF (milk fat globule membrane ready-to-use therapeutic food); Drug: Amoxicillin; Drug: Sulfadoxine (12.5 mg)/Pyrimethamine (250 mg)

S-RUTF (standard ready-to-use therapeutic food)

ACTIVE COMPARATOR

One sachet contains 92g of S-RUTF. During SAM treatment, each participant will be given sufficient S-RUTF to consume 2 sachets per day, which will provide approximately 1000 calories, 27g of protein, 60g of fat, and over 1 RDA of micronutrients.

Dietary Supplement: S-RUTF (standard ready-to-use therapeutic food); Drug: Amoxicillin; Drug: Sulfadoxine (12.5 mg)/Pyrimethamine (250 mg)

Interventions

S-RUTF (standard ready-to-use therapeutic food) DIETARY_SUPPLEMENT

Standard peanut paste-based ready-to-use therapeutic food made with skim milk powder meeting Codex Alimentarius specifications. This RUTF is modeled on the most widely used recipe worldwide, containing per 100g: 19.5g skim milk powder, 9.3g palm oil, 7g canola oil, 31.3g peanut paste, 28g sugar, 1g soy flakes, 1g hydrogenated vegetable oil, and 2.9g micronutrient mix.

S-RUTF (standard ready-to-use therapeutic food)

Sulfadoxine (12.5 mg)/Pyrimethamine (250 mg) DRUG

Malaria chemoprophylaxis, dosed by weight, to be given every month during SAM treatment

MFGM-RUTF (Milk fat globule membrane ready-to-use therapeutic food); S-RUTF (standard ready-to-use therapeutic food)

MFGM-RUTF (milk fat globule membrane ready-to-use therapeutic food) DIETARY_SUPPLEMENT

MFGM whey protein/fat concentrate powder used in place of skim milk powder in peanut paste-based ready-to-use therapeutic food meeting Codex Alimentarius specifications. There will be 10g of MFGM-containing whey protein/fat concentrate powder per 100g of MFGM-RUTF. Other ingredients and amounts per 100g: 9.5g rice flour, 5g whey permeate, 18.5g palm oil, 31g peanut paste, 22.1g sugar, 2.9g micronutrient mix, 1g fish oil.

MFGM-RUTF (Milk fat globule membrane ready-to-use therapeutic food)

Amoxicillin DRUG

Oral amoxicillin tablets twice per day for 7 days dosed based on weight

MFGM-RUTF (Milk fat globule membrane ready-to-use therapeutic food); S-RUTF (standard ready-to-use therapeutic food)

Eligibility Criteria

• Age: 6 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Project Peanut Butter: collaborator
• Ministry of Health and Sanitation, Sierra Leone: collaborator
• Arla Food Ingredients Group P/S: collaborator
• The Danish Dairy Research Foundation, Denmark: collaborator
• Washington University School of Medicine: lead

Study Sites (10)

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

MeSH Terms

Conditions

Severe Acute Malnutrition; Cognitive Dysfunction; Kwashiorkor; Cachexia

Interventions

Amoxicillin; Sulfadoxine; Pyrimethamine

Condition Hierarchy (Ancestors)

Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Benzenesulfonamides; Sulfonamides; Sulfanilamides; Aniline Compounds; Amines; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Mark J Manary, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

• Kevin B Stephenson, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

• Indi Trehan, MD, MPH

  University of Washington

  STUDY DIRECTOR

Central Study Contacts

Mark J Manary, MD

CONTACT

+1 314-454-2341; manarymj@wustl.edu

Kevin B Stephenson, MD

CONTACT

+1-314-749-8849; k.stephenson@wustl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2025
• First Posted: March 11, 2025
• Study Start: September 22, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Within 12 months of primary publication

Locations

SI (10)