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

MODAM-SAM

Protocols for the community-based management of acute malnutrition (CMAM) have not changed significantly for more than 20 years, with relatively complex treatment protocols and persistent supply chain challenges that have limited overall program coverage, leaving millions of malnourished children without care annually. The overarching goal of this research project is to simultaneously test two novel simplified approaches in CMAM with potential to improve program coverage. The simplified approach includes two parallel clinical trials for SAM and MAM treatment. Two fixed-dose regimes of RUTF will be tested against the current weight-based dosing of RUTF for children with SAM.

2023-09-25

2026-09-25

2026-09-25

Not yet recruiting

2400

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 (will not count towards planned sample size) 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

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 2400, 'type': 'ESTIMATED'}}

2023-09-29