Actively Recruiting

Phase Not Applicable
Age: 6Months - 59Months
All Genders
NCT06061484

Modified Dosage for Severe Acute Malnutrition

Led by Action Against Hunger USA · Updated on 2024-07-16

2400

Participants Needed

3

Research Sites

156 weeks

Total Duration

On this page

Sponsors

A

Action Against Hunger USA

Lead Sponsor

U

University of Washington

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Modified Dosage for Severe Acute Malnutrition

Who Can Participate

Age: 6Months - 59Months
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 6-59 months
  • Reside in the catchment area of the health post without plans to leave over the next year
  • Have uncomplicated severe acute malnutrition without signs of severe illness needing inpatient care
  • Pass an appetite test at enrollment
  • Consent given by mother, father, or primary caregiver
  • Mid-upper arm circumference less than 115 mm and/or nutritional edema
  • Weight-for-height Z-score less than -3
Not Eligible

You will not qualify if you...

  • Have complicated acute malnutrition with severe illness requiring hospitalization, including hypothermia, high fever, hypoglycemia, lethargy, severe dehydration, or shock
  • Received treatment for acute malnutrition as inpatient or outpatient in past 3 months
  • Known chronic medical illnesses such as severe cerebral palsy, severe congenital anomalies, Down syndrome, hydrocephalus, unrepaired cleft lip or palate, or other conditions affecting feeding

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 3 locations

1

Sekota

Sekota, Amhara, Ethiopia

Not Yet Recruiting

2

Teltele

Teltelē, Oromiya, Ethiopia

Actively Recruiting

3

Gode

Gode, Somali, Ethiopia

Actively Recruiting

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Research Team

I

Indi Trehan, MD MPH DTM&H

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Modified Dosage for Severe Acute Malnutrition | DecenTrialz