Choline to Prevent SAM in Children With MAM

NCT06214897 | Active Not Recruiting

• 1 other identifier: 202308159
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 10

Brief Summary

The goal of this clinical trial is to test choline supplementation in children with moderate acute malnutrition in Malawi. The main question it aims to answer is: Will provision of RUSF with added choline (500mg/day) throughout treatment of moderate acute malnutrition (up to 12 weeks) reduce deterioration to severe acute malnutrition among 6-59 month old Malawian children compared with standard RUSF?

Conditions

Moderate Acute Malnutrition

Outcome Measures

Primary Outcomes (1)

• Percentage of pairwise comparisons with wins of Clinical Benefit, which is a composite of time-to-SAM, graduation, and rate of weight change between enrollment and 4-week follow-up.

  Clinical benefit is defined as a composite of time-to-SAM, graduation, and rate of weight change. Each participant randomized to C-RUSF is compared to each participant randomized to S-RUSF. For any two participants, a participant will win, i.e. achieve a better clinical outcome, as determined by assessing the following criteria sequentially, stopping when an advantage for either participant is shown: Time-to-SAM: developing SAM faster is worse than slower; tied if not possible to determine. Graduation: graduating is better than not graduating; tied if not possible to determine. Rate of weight change: more positive rate of weight change is better. Rate of weight change is difference in weight (g) between the second follow-up visit and the enrollment visit, divided by enrollment weight (kg), divided by the (d) time elapsed between visits. If the participant lacks data beyond the first follow-up visit, this data will be used instead.

  2-12 weeks of supplementary feeding

Secondary Outcomes (22)

• Deterioration to SAM

  2-12 weeks of supplementary feeding

• Graduation

  2-12 weeks of supplementary feeding

• Rate of weight change

  Across first 4 weeks of supplementary feeding

• Death

  From enrollment to end of participant's engagement (at latest, time of 6-month post-outcome MDAT testing)

• Deterioration to kwashiorkor

  2-12 weeks of supplementary feeding

Other Outcomes (2)

• MDAT global z-score by age

  6-month post-outcome MDAT visit

• MDAT global z-score by MAM outcome status

  6-month post-outcome MDAT visit

Study Arms (2)

C-RUSF (Ready-to-use Supplemental Food with added choline)

EXPERIMENTAL

A daily dose of 500 Kcal of RUSF containing 500mg choline will be provided

Dietary Supplement: C-RUSF (Ready-to-use Supplemental Food with added Choline)

S-RUSF (Standard Ready-to-use Supplemental Food without added choline)

ACTIVE COMPARATOR

A daily dose of 500 Kcal of RUSF without choline

Dietary Supplement: S-RUSF (Ready-to-use Supplemental Food without added Choline)

Interventions

S-RUSF (Ready-to-use Supplemental Food without added Choline) DIETARY_SUPPLEMENT

Standard Ready-to-use Supplemental Food

S-RUSF (Standard Ready-to-use Supplemental Food without added choline)

C-RUSF (Ready-to-use Supplemental Food with added Choline) DIETARY_SUPPLEMENT

Ready-to-use Supplemental Food with added Choline

C-RUSF (Ready-to-use Supplemental Food with added choline)

Eligibility Criteria

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

You may qualify if:

• months of age
• uncomplicated MAM (mid-upper arm circumference (MUAC) ≥ 11.5 cm and \< 12.5 cm and/or weight-for-length z-score (WLZ) ≥ -3 and \< -2)
• availability for the duration of the study with no plan to move from the catchment area of a participating clinic

You may not qualify if:

• presence of nutritional edema
• features of complicated MAM, such as mental status changes or breathing issues
• participation in another feeding program
• known allergy to study food ingredient
• intention to move away from catchment area within 9 months
• developmental delay
• presence of a chronic severe medical condition (other than TB or HIV) such as congenital heart disease

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Project Peanut Butter: collaborator
• Kamuzu University of Health Sciences: collaborator
• Balchem Corp: collaborator

Study Sites (10)

Chikonde Health Center

Chikonde, Malawi

Location

Chipolonga Health Center

Chipolonga, Malawi

Location

Makhwira Health Center

Makhwira, Malawi

Location

Mbiza Health Clinic

Mbiza, Malawi

Location

Milonde Health Center

Milonde, Malawi

Location

Mitondo Health Center

Mitondo, Malawi

Location

Muloza Health Clinic

Muloza, Malawi

Location

Namasalima Health Center

Namasalima, Malawi

Location

Naphimba Health Center

Naphimba, Malawi

Location

Nkhate Health Clinic

Nkhate, Malawi

Location

Study Officials

• Mark J Manary, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The intervention and control sachets of RUSF will be packaged such that investigators, outcomes assessors, and participants/caregivers will not know their identity.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2023
• First Posted: January 22, 2024
• Study Start: March 18, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

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

Locations

MA (10)