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

ConditionsSevere Acute Malnutrition Cognitive Impairment Kwashiorkor Severe Wasting

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

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.
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.
Amoxicillin
Drug
Oral amoxicillin tablets twice per day for 7 days dosed based on weight
Sulfadoxine (12.5 mg)/Pyrimethamine (250 mg)
Drug
Malaria chemoprophylaxis, dosed by weight, to be given every month during SAM treatment

Treatment groups

1,600 Participants

are divided into 2 treatment groups

Group A: MFGM-RUTF (Milk fat globule membrane ready-to-use therapeutic food)Experimental treatment 3 interventions

Group B: S-RUTF (standard ready-to-use therapeutic food)Active comparator 3 interventions

Trial outcomes

Primary outcomes

Malawi Developmental Assessment Tool global z-score

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

Time frame

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

Time frame

2-12 weeks of therapeutic feeding

Secondary outcomes

Malawi Developmental Assessment Tool gross motor domain z-score

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

Time frame

6 (5-7) months after SAM treatment completion

Malawi Developmental Assessment Tool fine motor domain z-score

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

Time frame

6 (5-7) months after SAM treatment completion

Malawi Developmental Assessment Tool language domain z-score

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

Time frame

6 (5-7) months after SAM treatment completion

Malawi Developmental Assessment Tool social-emotional domain z-score

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

Time frame

6 (5-7) months after SAM treatment completion

Other outcomes

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

Age-standardized score, -6 to +6, higher scores are better. Will be tested in subgroups based on SAM treatment outcome (graduation vs. other), age at enrollment, and sex

Time frame

6 (5-7) months after SAM outcome

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

Age-standardized score, -6 to +6, higher scores are better. Will be tested in subgroups based on SAM treatment outcome (graduation vs. other), age at enrollment, and sex

Time frame

Within 1 month of 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. This will be tested in subgroups by age at enrollment, sex, and enrollment criteria.

Time frame

2-12 weeks of therapeutic feeding

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

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