Alternative RUTFs for Treatment of Child Wasting

Efficacy of Alternative RUTFs for Treatment of Child Wasting and Prevention of Relapse

Acute malnutrition is the most life-threatening form of undernutrition. Moderate and severe acute malnutrition (MAM, SAM) are effectively treated with ready-to-use therapeutic foods (RUTFs) but there is a need to lower the cost of treatment and improve treatment regimens to reduce risk of relapse MAM/SAM episodes following recovery. The currently used standard formulation of RUTF contains peanuts and dairy, which pose problems due to their high cost, the need to import ingredients to the Global South (in the case of dairy), and risk of aflatoxin (in the case of peanuts). Before alternative formulations of RUTF can be recommended, however, there is the need for data on the efficacy of these formulations on recovery rates and to what extent recovery is sustainable. Sustainable recovery implies a lower rate of post-treatment relapse.

The study objectives are as follows: (1) To assess the non-inferiority of soy-maize-sorghum (SMS-) RUTF and soy-based (S-) RUTF on treatment recovery to standard RUTF; (2) To assess the superiority of SMS-RUTF and S- RUTF on post-recovery relapse compared to standard RUTF; (3) To assess the costs of a treatment course of SMS-RUTF, S-RUTF, and standard RUTF; (4) To assess the effect of SMS-RUTF and S-RUTF on microbiome composition and intestinal inflammation

The investigators will conduct a facility-based, individually randomized controlled trial with three arms allocated in a 1:1:1 allocation ratio in 30 health facilities (Centre de Santé et Promotion Sociale [CSPS]) in Burkina Faso. The investigators will randomize 1080 children with MAM and 1080 children with uncomplicated SAM 6-59 months of age to receive treatment with one of the following RUTFs: (1) standard of care, milk- and peanut-based RUTF (control group); (2) SMS-RUTF free of milk and peanuts and high in fiber (intervention 1); or (3) S-RUTF free of milk and peanuts (intervention 2). Children will be enrolled upon presentation to facilities for MAM or uncomplicated SAM treatment. Follow up visits will be weekly during treatment for SAM children and bi-weekly during treatment for MAM children, and monthly for 3 months following discharge from treatment. The primary study outcomes include, among others, anthropometric recovery at discharge (a non-inferiority analysis) and relapse to MAM or SAM within the 3 months following recovery (a superiority analysis). The investigators will employ an activity-based micro-costing approach to collect cost data on the direct and indirect medical costs, opportunity costs to caregivers, personnel, and overheads associated with outpatient MAM or SAM treatment. Fecal samples will be collected from children at a subset of facilities (5 facilities, ~60 children per treatment arm), at enrollment (initiation of treatment), discharge from treatment, and 3-months post-discharge.

Study Overview

• Status: Completed
• Conditions: Wasting; Moderate Acute Malnutrition; Severe Acute Malnutrition
• Intervention / Treatment: Dietary supplement: Standard RUTF; Dietary supplement: Soy-based RUTF; Dietary supplement: Soy-maize-sorghum-based RUTF

• Study Type: Interventional
• Enrollment (Actual): 2269
• Phase: Phase 3

Contacts and Locations

Study Locations

• Burkina Faso
  • Bobo-Dioulasso, Burkina Faso
    • Health centers localted in the region of Hauts-Bassins

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 6-59 months
• MUAC < 12.5 cm, or WLZ/WHZ < -2
• Absence of clinical complications or nutritional edema
• Pass the appetite test
• Accompanied by caregiver or legal guardian
• Caregiver or legal guardian consents to participate

Exclusion Criteria:

• Acute malnutrition requiring hospitalization (presence of clinical complications, failure to pass the appetite test, or presence of bilateral pitting edema)
• Known allergy to any of the ingredients in the RUTF products
• Already enrolled in MAM or SAM treatment program
• Presence of physical abnormalities that make measurement of anthropometry impossible
• Caregiver has intention to move out of the study area within the next 6 months
• Children referred from in-patient facilities to continue in ambulatory care

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard RUTF; This is the control arm of the trial, in which children will receive the standard RUTF product for treatment of acute malnutrition	Dietary supplement: Standard RUTF; This is the control, the standard, currently used formulation of ready-to-use therapeutic foods (RUTFs), which contains dairy and peanut ingredients
Experimental: Soy-based RUTF; This is an interventional arm of the trial, in which children will receive an alternative formulation, a soy-based RUTF	Dietary supplement: Soy-based RUTF; This alternative formulation of ready-to-use therapeutic foods (RUTFs) is a peanut-free formula that includes dairy (milk powder) with added crystalline amino acids
Experimental: Soy-maize-sorghum-based RUTF; This is an interventional arm of the trial, in which children will receive an alternative formulation, a soy-maize-sorghum-based RUTF	Dietary supplement: Soy-maize-sorghum-based RUTF; This alternative formulation of ready-to-use therapeutic foods (RUTFs) is a peanut-free and dairy-free formula with added crystalline amino acids

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anthropometric recovery	Weight-for-length z-score (WLZ) ≥ -2 and middle upper arm circumference (MUAC) ≥ 125 mm and absence of bilateral pitting edema for two consecutive visits	At discharge, which is up to 12 weeks after admission
Default from treatment	Child is absent for two consecutive visits, declared a defaulter on the second visit	During treatment, which is up to 12 weeks after admission
Relapse to wasting	A new episode of wasting (defined as weight-for-length/height z-score [WLZ/WHZ] < -2 or middle upper arm circumference [MUAC] < 125 mm or presence of bilateral pitting edema) within the 3-month period following recovery from the index wasting episode, among children who recovered from their index episode	Within 3 months post-discharge
Transfer to inpatient treatment	Referral or admission to hospital for inpatient treatment during the treatment course	During treatment, which is up to 12 weeks after admission
Weight gain	Change in child's weight (gram/kilogram/day) between weight on day of admission to treatment and day of discharge	During treatment, which is up to 12 weeks after admission
Non-response to treatment	Any of the following criteria are met: Absence of weight gain after 5 weeks or at the third visit; weight loss for more than 4 weeks in the program or at the second visit; loss of more than 5% of body weight compared to admission weight at any time; or anthropometric recovery criteria not met after 3 months of follow-up in treatment	During treatment, which is up to 12 weeks after admission
Adherence to treatment services	Caregiver attends the recommended schedule of visits and receive ready-to-use therapeutic foods (RUTF) supply	During treatment, which is up to 12 weeks after admission
Length of stay	The number of days between the day the child is admitted to treatment and the day the child is determined to be recovered and thus discharged from treatment	During treatment, which is up to 12 weeks after admission
Anthropometry	Weight-for-length/height z-score (WLZ/WHZ), middle upper arm circumference (MUAC), weight, height/length, length/height-for-age z-score (LAZ/HAZ) and weight-for-age z-score (WAZ)	At discharge, which is up to 12 weeks after admission
Relapse to MAM	A new episode of MAM (weight-for-length/height z-score [WLZ/WHZ] <-2 and ≥-3, or middle upper arm circumference [MUAC] <125 mm and ≥115 mm) within the 3-month period following recovery from the index wasting episode	Within 3 months post-discharge
Relapse to SAM	A new episode of SAM (weight-for-length/height z-score [WLZ/WHZ] < -3 or middle upper arm circumference [MUAC] < 115 mm or presence of bilateral pitting edema) within the 3-month period following recovery from the index wasting episode	Within 3 months post-discharge
Anthropometry	Weight-for-length/height z-score (WLZ/WHZ), middle upper arm circumference (MUAC), weight, height/length, length/height-for-age z-score (LAZ/HAZ) and weight-for-age z-score (WAZ)	At 3 months post-discharge
Hemoglobin	Hemoglobin concentration (grams/liter)	At discharge, which is up to 12 weeks after admission
Hemoglobin	Hemoglobin concentration (grams/liter)	At 3 months post-discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morbidity	Indication of morbidity (acute respiratory infections, diarrhea, fever, or malaria) on health center card	During treatment, which is up to 12 weeks after admission
Anemia	Hemoglobin concentration < 105 gram/liter for children 6-23 months of age Hemoglobin concentration < 110 gram/liter for children 24-59 months of age	At discharge, which is up to 12 weeks after admission
Anemia	Hemoglobin concentration < 110 gram/liter	At 3 months post-discharge
Mortality	Child has deceased	During treatment, which is up to 12 weeks after admission, or during the 3-month post-discharge follow up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability	Observed dose intake/consumed (grams)	After 7 days of product trial

Collaborators and Investigators

• Sponsor: International Food Policy Research Institute
• Collaborators: Institut de Recherche en Sciences de la Sante, Burkina Faso; AFRICSante
• Investigators: Principal Investigator: Laeticia Toe, Institut de Recherche en Sciences de la Santé

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2025
• Primary Completion (Actual): April 30, 2026
• Study Completion (Actual): April 30, 2026

Study Registration Dates

• First Submitted: March 19, 2025
• First Submitted That Met QC Criteria: April 2, 2025
• First Posted (Actual): April 6, 2025

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Severe Acute Malnutrition; Wasting; Moderate Acute Malnutrition; Ready-to-use Therapeutic Foods; RUTFs; Wasting relapse; Plant-based RUTF; Dairy-free RUTF; Peanut-free RUTF
• Additional Relevant MeSH Terms: Nutrition Disorders; Body Weight; Body Weight Changes; Malnutrition; Weight Loss; Thinness; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Severe Acute Malnutrition; Cachexia
• Other Study ID Numbers: 2024-RUTF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: In accordance with the International Food Policy Research Institute's policy on research data management and open access, at the time of publication of scientific articles presenting results, the fully anonymized databases will become a public good and will be made available to the scientific community, government, and partners.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No