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| Name | Class |
|---|---|
| AFRICSante | UNKNOWN |
| Institut de Recherche en Sciences de la Sante, Burkina Faso | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Soy-based RUTF | Experimental | This is an interventional arm of the trial, in which children will receive an alternative formulation, a 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability | Observed dose intake/consumed (grams) | After 7 days of product trial |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laeticia Toe | Institut de Recherche en Sciences de la Santé | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Health centers localted in the region of Hauts-Bassins | Bobo-Dioulasso | Burkina Faso |
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.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 16, 2025 | Jan 29, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 20, 2026 | Jan 29, 2026 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000067011 | Severe Acute Malnutrition |
| D002100 | Cachexia |
| ID | Term |
|---|---|
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D015431 | Weight Loss |
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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.
| 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 |
|
| 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 |
|
| 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 |
| 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 |
| D001836 |
| Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013851 | Thinness |