Testing new treatment methods for severe acute malnutrition in children

Safety Efficacy, and Cost-effectiveness of Modified Doses of Ready-to-use Therapeutic Food for the Treatment of Severe Acute Malnutrition Among Children 6-59 Months of Age in Ethiopia

This study is testing two new ways to treat severe malnutrition in young children using ready-to-eat food to see if they work better than the usual method.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 2400 (estimated)
• Ages: 6 Months to 59 Months
• Sex: All
• Sponsor: Action Against Hunger USA (Academic / other)
• Locations: 3 sites (Sekota, Amhara and 2 other locations)
• Trial ID: NCT06061484 on ClinicalTrials.gov

What this trial studies

This research project aims to improve the management of severe acute malnutrition (SAM) in children by testing two simplified treatment approaches using ready-to-use therapeutic food (RUTF). The study will compare two fixed-dose regimes of RUTF against the traditional weight-based dosing method. By streamlining treatment protocols, the goal is to enhance program coverage and ensure more malnourished children receive the necessary care. The trial will be conducted in community health settings in Ethiopia, focusing on children aged 6-59 months with uncomplicated SAM.

Who should consider this trial

Good fit: Ideal candidates for this study are children aged 6-59 months with uncomplicated severe acute malnutrition living in the trial catchment areas.

Not a fit: Patients with complicated acute malnutrition requiring hospitalization or higher-level medical evaluation will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly increase the number of children receiving effective treatment for severe acute malnutrition.

How similar studies have performed: Other studies have shown promise in simplifying treatment protocols for malnutrition, but this specific approach is novel.

Eligibility criteria

Inclusion Criteria:

1. Age 6-59 months
2. Reside in the catchment area of the health post where the trial is to be conducted without plans to leave the area over the next year
3. Uncomplicated severe acute malnutrition, as defined by no signs of severe illness that would require referral to inpatient facility
4. Pass appetite test conducted at the time of enrollment
5. Consent for randomization into the study given by mother, father, and/or other primary caregiver
6. Mid-upper arm circumference less than 115 mm and/or nutritional edema
7. Weight-for-height Z-score (WHZ) less than -3

Exclusion Criteria:

1. Complicated acute malnutrition with severe illness requiring transfer to a stabilization center or hospital for treatment. This includes, but is not limited to: a. Hypothermia b. High fever c. Signs of hypoglycemia d. Lethargy or altered mental status e. Moderate to severe dehydration f. Shock g. Other medical complications requiring hospitalization or higher-level medical evaluation
2. Treatment for acute malnutrition, either as an inpatient or outpatient, within the past 3 months
3. Known chronic medical illness such as severe cerebral palsy, severe congenital anomalies such as unrepaired congenital heart disease, Down syndrome, hydrocephalus, unrepaired cleft lip or palate, or other conditions that would be expected to contribute to difficulty feeding the prescribed amounts of therapeutic or supplementary food

Where this trial is running

Sekota, Amhara and 2 other locations

• Sekota — Sekota, Amhara, Ethiopia (Not_yet_recruiting)
• Teltele — Teltelē, Oromiya, Ethiopia (Recruiting)
• Gode — Gode, Somali, Ethiopia (Recruiting)

Study contacts

• Principal investigator: Heather C Stobaugh, PhD — Action Against Hunger USA
• Study coordinator: Indi Trehan, MD MPH DTM&H

Conditions Severe Acute Malnutrition