NCT06061484

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,400 (estimated)
• Sponsor: Action Against Hunger USA · Academic / Other
• Sex: All
• Age: 6 Months – 59 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Severe Acute Malnutrition

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	ready-to-use therapeutic food (RUTF)	Standard formulation meeting UNICEF specifications: https://www.unicef.org/supply/sites/unicef.org.supply/files/2023-04/U239977-RUTF-Novel-Specification.pdf
DRUG	Amoxicillin	Standard weight-based dosing per Ehtiopian national guidelines

Timeline

• Start date: 2023-09-25
• Primary completion: 2026-09-25
• Completion: 2026-09-25
• First posted: 2023-09-29
• Last updated: 2024-07-16

Locations

3 sites across 1 country: Ethiopia