Alternative RUTFs for Treatment of Child Wasting

NCT06912620 | Recruiting Phase 3 DMC

• 1 other identifier: 2024-RUTF
• Study Type: interventional
• Target: 2,160
• Locations: 1 country
• Sites: 1

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.

Conditions

Severe Acute Malnutrition; Moderate Acute Malnutrition; Wasting

Keywords

Severe Acute Malnutrition; Moderate Acute Malnutrition; Wasting; Ready-to-use Therapeutic Foods; RUTFs; Wasting relapse; Plant-based RUTF; Dairy-free RUTF; Peanut-free RUTF

Outcome Measures

Primary Outcomes (14)

• 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 Outcomes (4)

• Morbidity

  During treatment, which is up to 12 weeks after admission

• Anemia

  At discharge, which is up to 12 weeks after admission

• Anemia

  At 3 months post-discharge

• Mortality

  During treatment, which is up to 12 weeks after admission, or during the 3-month post-discharge follow up

Other Outcomes (1)

• Acceptability

  After 7 days of product trial

Study Arms (3)

Standard RUTF

ACTIVE COMPARATOR

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

Soy-based RUTF

EXPERIMENTAL

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

Soy-maize-sorghum-based RUTF

EXPERIMENTAL

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

Interventions

Soy-based RUTF DIETARY_SUPPLEMENT

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

Soy-based RUTF

Soy-maize-sorghum-based RUTF DIETARY_SUPPLEMENT

This alternative formulation of ready-to-use therapeutic foods (RUTFs) is a peanut-free and dairy-free formula with added crystalline amino acids

Soy-maize-sorghum-based RUTF

Standard RUTF DIETARY_SUPPLEMENT

This is the control, the standard, currently used formulation of ready-to-use therapeutic foods (RUTFs), which contains dairy and peanut ingredients

Standard RUTF

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• International Food Policy Research Institute: lead
• AFRICSante: collaborator
• Institut de Recherche en Sciences de la Sante, Burkina Faso: collaborator

Study Sites (1)

Health centers localted in the region of Hauts-Bassins

Bobo-Dioulasso, Burkina Faso

RECRUITING

MeSH Terms

Conditions

Severe Acute Malnutrition; Cachexia

Condition Hierarchy (Ancestors)

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

Study Officials

• Laeticia Toe

  Institut de Recherche en Sciences de la Santé

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebecca Brander

CONTACT

+1 (202) 862-5600; r.brander@cgiar.org

Lieven Huybregts

CONTACT

l.huybregts@cgiar.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The products will be provided in identical packaging and the participants, the care providers, the investigators, and outcomes assessors will be blinded to treatment assessment. However, the products may taste different and thus participants may know that they are receiving an alternative RUTF if they are familiar with the standard RUTF product.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2025
• First Posted: April 6, 2025
• Study Start: March 21, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

BU (1)