Alternative RUTFs for Treatment of Child Wasting

International Food Policy Research Institute

Status and phase: Enrolling; Phase 3

Conditions: Wasting; Severe Acute Malnutrition; Moderate Acute Malnutrition

Treatments: Dietary Supplement: Soy-maize-sorghum-based RUTF; Dietary Supplement: Standard RUTF; Dietary Supplement: Soy-based RUTF

Study type: Interventional

Funder types: Other

Identifiers

NCT06912620

2024-RUTF

Details and patient eligibility

About

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.

Enrollment: 2,160 estimated patients

Sex: All

Ages: 6 to 59 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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2,160 participants in 3 patient groups

Standard RUTF

Active Comparator group

Description:

This is the control arm of the trial, in which children will receive the standard RUTF product for treatment of acute malnutrition

Treatment:

Dietary Supplement: Standard RUTF

Soy-based RUTF

Experimental group

Description:

This is an interventional arm of the trial, in which children will receive an alternative formulation, a soy-based RUTF

Treatment:

Dietary Supplement: Soy-based RUTF

Soy-maize-sorghum-based RUTF

Experimental group

Description:

This is an interventional arm of the trial, in which children will receive an alternative formulation, a soy-maize-sorghum-based RUTF

Treatment:

Dietary Supplement: Soy-maize-sorghum-based RUTF