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Modified Dosage for Severe Acute Malnutrition

NCT06061484 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2400

Last updated 2024-07-16

No results posted yet for this study

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

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

Sponsors & Collaborators

  • University of Washington

    collaborator OTHER

  • Ethiopian Public Health Institute

    collaborator OTHER_GOV

  • Action Against Hunger USA

    lead OTHER

Principal Investigators

  • Heather C Stobaugh, PhD · Action Against Hunger USA

  • Indi Trehan, MD MPH DTM&H · University of Washington

  • Yosef B Asefaw, MSc · Ethiopian Public Health Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
59 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-25
Primary Completion
2026-09-25
Completion
2026-09-25

Countries

  • Ethiopia

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06061484 on ClinicalTrials.gov