Modified Dosage for Severe Acute Malnutrition
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
Action Against Hunger USA
2,400 participants
Sep 25, 2023
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria7
- Age 6-59 months
- 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
- Uncomplicated severe acute malnutrition, as defined by no signs of severe illness that would require referral to inpatient facility
- Pass appetite test conducted at the time of enrollment
- Consent for randomization into the study given by mother, father, and/or other primary caregiver
- Mid-upper arm circumference less than 115 mm and/or nutritional edema
- Weight-for-height Z-score (WHZ) less than -3
Exclusion Criteria3
- 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
- Treatment for acute malnutrition, either as an inpatient or outpatient, within the past 3 months
- 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
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Interventions
Standard formulation meeting UNICEF specifications: https://www.unicef.org/supply/sites/unicef.org.supply/files/2023-04/U239977-RUTF-Novel-Specification.pdf
Standard weight-based dosing per Ehtiopian national guidelines
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06061484