Testing new food formulas for treating child malnutrition
Efficacy of Alternative RUTFs for Treatment of Child Wasting and Prevention of Relapse
This study tests new types of ready-to-eat foods to see if they can help young children recover from malnutrition better than the usual peanut and dairy-based options.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 2160 (estimated) |
| Ages | 6 Months to 59 Months |
| Sex | All |
| Sponsor | International Food Policy Research Institute Academic / other |
| Locations | 1 site (Bobo-Dioulasso) |
| Trial ID | NCT06912620 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of alternative ready-to-use therapeutic foods (RUTFs) for treating severe and moderate acute malnutrition in children aged 6 to 59 months. It compares the recovery rates of soy-maize-sorghum-based RUTF and soy-based RUTF against the standard peanut and dairy-based RUTF. The study aims to determine if these alternative formulations can provide a cost-effective and sustainable solution to malnutrition while minimizing the risk of relapse. Participants will be monitored for recovery and sustainability of treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 6 to 59 months who are diagnosed with moderate or severe acute malnutrition without clinical complications.
Not a fit: Patients who are severely malnourished and require hospitalization or have allergies to the ingredients in the RUTF products will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide more affordable and effective treatment options for children suffering from acute malnutrition.
How similar studies have performed: Previous studies have shown that alternative formulations of RUTF can be effective, but this specific approach is being tested for the first time in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bobo-Dioulasso
- Health centers localted in the region of Hauts-Bassins — Bobo-Dioulasso, Burkina Faso (Recruiting)
Study contacts
- Principal investigator: Laeticia Toe — Institut de Recherche en Sciences de la Santé
- Study coordinator: Rebecca Brander
- Email: r.brander@cgiar.org
- Phone: +1 (202) 862-5600
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.