Alternative RUTFs for Treatment of Child Wasting

Phase 3

Recruiting

• Conditions: Severe Acute Malnutrition; Moderate Acute Malnutrition; Wasting

• Registration Number: NCT06912620
• Lead Sponsor: International Food Policy Research Institute

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-19
• Study Start: 2025-03-21
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-02
• Last Update Submitted: 2025-04-02
• Study First Posted: 2025-04-06
• Last Update Posted: 2025-04-06
• Primary Completion: 2026-03
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2160

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Relapse to wasting	Within 3 months post-discharge	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
Transfer to inpatient treatment	During treatment, which is up to 12 weeks after admission	Referral or admission to hospital for inpatient treatment during the treatment course
Non-response to treatment	During treatment, which is up to 12 weeks after admission	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
Adherence to treatment services	During treatment, which is up to 12 weeks after admission	Caregiver attends the recommended schedule of visits and receive ready-to-use therapeutic foods (RUTF) supply
Length of stay	During treatment, which is up to 12 weeks after admission	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
Anthropometric recovery	At discharge, which is up to 12 weeks after admission	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
Default from treatment	During treatment, which is up to 12 weeks after admission	Child is absent for two consecutive visits, declared a defaulter on the second visit
Weight gain	During treatment, which is up to 12 weeks after admission	Change in child's weight (gram/kilogram/day) between weight on day of admission to treatment and day of discharge
Anthropometry	At 3 months post-discharge	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)
Relapse to MAM	Within 3 months post-discharge	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
Relapse to SAM	Within 3 months post-discharge	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
Hemoglobin	At 3 months post-discharge	Hemoglobin concentration (grams/liter)

Secondary Outcome Measures

Name	Time	Method
Anemia	At 3 months post-discharge	Hemoglobin concentration \< 110 gram/liter
Morbidity	During treatment, which is up to 12 weeks after admission	Indication of morbidity (acute respiratory infections, diarrhea, fever, or malaria) on health center card
Mortality	During treatment, which is up to 12 weeks after admission, or during the 3-month post-discharge follow up	Child has deceased

Trial Locations

Locations (1)

Health centers localted in the region of Hauts-Bassins; 🇧🇫 Bobo-Dioulasso, Burkina Faso