Testing new food treatments for children with moderate acute malnutrition

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

This study is testing two new food treatments for children with moderate acute malnutrition to see which one helps them get better faster.

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: NCT06056089 on ClinicalTrials.gov

What this trial studies

This research project aims to improve the management of moderate acute malnutrition (MAM) in children by testing two simplified treatment approaches using ready-to-use therapeutic food (RUTF) and ready-to-use supplementary food (RUSF). The study will compare two fixed-dose regimens of RUTF against the current regimen of RUSF to determine which is more effective in treating MAM. The trial will be conducted in community health settings, focusing on children aged 6-59 months who meet specific eligibility criteria. The goal is to enhance program coverage and accessibility for malnourished children.

Who should consider this trial

Good fit: Ideal candidates for this study are children aged 6-59 months with uncomplicated moderate acute malnutrition living in the catchment area of the health post.

Not a fit: Patients with complicated acute malnutrition or severe illness requiring hospitalization will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly improve the treatment options and outcomes for children suffering from moderate acute malnutrition.

How similar studies have performed: Other studies have shown success with simplified approaches in managing acute malnutrition, but this specific methodology is relatively 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 moderate 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 of 115-124 mm without nutritional edema
7. Weight-for-height Z-score (WHZ) between -2 and -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 — Action Against Hunger USA
• Study coordinator: Indi Trehan, MD MPH DTM&H

Conditions Moderate Acute Malnutrition