Severe Acute MalnutritionPhase 3NCT06912620
Alternative RUTFs for Treatment of Child Wasting
A Phase 3 study testing Soy-based RUTF, Soy-maize-sorghum-based RUTF and Standard RUTF in people with Severe Acute Malnutrition and Moderate Acute Malnutrition, run by International Food Policy Research Institute at 1 site in Burkina Faso.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 59 months
- Conditions the study is for
- Severe Acute Malnutrition, Moderate Acute Malnutrition, Wasting
- What is being tested?
- Soy-based RUTF, Soy-maize-sorghum-based RUTF and Standard RUTF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,269 participants
- Where
- 1 siteBurkina Faso
- Study dates
- 21 Mar 2025to 30 Apr 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Burkina Faso1 site
Health centers localted in the region of Hauts-Bassins
Bobo-Dioulasso
About this study
Official title: 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.
- Being tested
- Soy-based RUTF, Soy-maize-sorghum-based RUTF, Standard RUTF
- 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
- Medical subject headings
- Severe Acute Malnutrition, Cachexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soy-based RUTFDietary 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-maize-sorghum-based RUTFDietary 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 RUTFDietary supplement
This is the control, the standard, currently used formulation of ready-to-use therapeutic foods (RUTFs), which contains dairy and peanut ingredients
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Dietary Supplement: Soy-maize-sorghum-based RUTF |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: Within 3 months post-discharge
Transfer to inpatient treatment
Referral or admission to hospital for inpatient treatment during the treatment course
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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)
Measured: At 3 months post-discharge
Hemoglobin
Hemoglobin concentration (grams/liter)
Measured: At discharge, which is up to 12 weeks after admission
Hemoglobin
Hemoglobin concentration (grams/liter)
Measured: At 3 months post-discharge
Secondary outcomes (4)
Morbidity
Indication of morbidity (acute respiratory infections, diarrhea, fever, or malaria) on health center card
Measured: 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
Measured: At discharge, which is up to 12 weeks after admission
Anemia
Hemoglobin concentration < 110 gram/liter
Measured: At 3 months post-discharge
Mortality
Child has deceased
Measured: During treatment, which is up to 12 weeks after admission, or during the 3-month post-discharge follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start21 Mar 2025
- Primary completion30 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Acute MalnutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,269 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Food Policy Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- AFRICSante, Institut de Recherche en Sciences de la Sante, Burkina Faso
- Responsible party
- Sponsor
- Investigators
- Laeticia Toe, Principal investigator, Institut de Recherche en Sciences de la Santé
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06912620
- Sponsor's protocol ID
- 2024-RUTF
- Status last verified
- May 2026
- First submitted
- 19 Mar 2025
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Alternative RUTFs for Treatment of Child Wasting and Prevention of Relapse
- ClinicalTrials.gov ID
- NCT06912620
- Acronym / sponsor ID
- 2024-RUTF
- Keywords
- Severe Acute Malnutrition, Moderate Acute Malnutrition, Wasting, Ready-to-use Therapeutic Foods, RUTFs, Wasting relapse, Plant-based RUTF, Dairy-free RUTF
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,269 participants (actual)
- Lead sponsor
- International Food Policy Research InstituteUniversity, hospital or other
- Collaborators
- AFRICSante, Institut de Recherche en Sciences de la Sante, Burkina Faso
- Study start
- 21 Mar 2025 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 6 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard RUTF | Active comparator | Dietary Supplement: Standard RUTFThis 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 | Dietary Supplement: Soy-based RUTFThis 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 | Dietary Supplement: Soy-maize-sorghum-based RUTFThis is an interventional arm of the trial, in which children will receive an alternative formulation, a soy-maize-sorghum-based RUTF |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Soy-based RUTFThis alternative formulation of ready-to-use therapeutic foods (RUTFs) is a peanut-free formula that includes dairy (milk powder) with added crystalline amino acids | Dietary supplement | Soy-based RUTF |
| Soy-maize-sorghum-based RUTFThis alternative formulation of ready-to-use therapeutic foods (RUTFs) is a peanut-free and dairy-free formula with added crystalline amino acids | Dietary supplement | Soy-maize-sorghum-based RUTF |
| Standard RUTFThis is the control, the standard, currently used formulation of ready-to-use therapeutic foods (RUTFs), which contains dairy and peanut ingredients | Dietary supplement | Standard RUTF |
Primary outcome
Anthropometric recovery
Time frame: 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
Time frame: During treatment, which is up to 12 weeks after admission
Child is absent for two consecutive visits, declared a defaulter on the second visit
Relapse to wasting
Time frame: 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
Time frame: During treatment, which is up to 12 weeks after admission
Referral or admission to hospital for inpatient treatment during the treatment course
Weight gain
Time frame: 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
Non-response to treatment
Time frame: 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
Time frame: 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
Time frame: 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
Anthropometry
Time frame: At discharge, which is up to 12 weeks after admission
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
Time frame: 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
Time frame: 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
Anthropometry
Time frame: 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)
Hemoglobin
Time frame: At discharge, which is up to 12 weeks after admission
Hemoglobin concentration (grams/liter)
Hemoglobin
Time frame: At 3 months post-discharge
Hemoglobin concentration (grams/liter)
4 secondary outcomes
Morbidity
Time frame: During treatment, which is up to 12 weeks after admission
Anemia
Time frame: At discharge, which is up to 12 weeks after admission
Anemia
Time frame: At 3 months post-discharge
Mortality
Time frame: During treatment, which is up to 12 weeks after admission, or during the 3-month post-discharge follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laeticia Toe principal investigator
Institut de Recherche en Sciences de la Santé
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Soy-based RUTF, Soy-maize-sorghum-based RUTF and Standard RUTF in people with Severe Acute Malnutrition and Moderate Acute Malnutrition, run by International Food Policy Research Institute at 1 site in Burkina Faso.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Burkina Faso. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anthropometric recovery (time frame: At discharge, which is up to 12 weeks after admission). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.