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RECRUITING
NCT06061484
NA

Modified Dosage for Severe Acute Malnutrition

Sponsor: Action Against Hunger USA

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

6 Months - 59 Months

Study Type

INTERVENTIONAL

Enrollment

2400

Start Date

2023-09-25

Completion Date

2026-09-25

Last Updated

2024-07-16

Healthy Volunteers

No

Interventions

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

Locations (3)

Sekota

Sekota, Amhara, Ethiopia

Teltele

Teltelē, Oromiya, Ethiopia

Gode

Gode, Somali, Ethiopia