Actively Recruiting

Phase Not Applicable
Age: 6Months - 59Months
All Genders
NCT06056089

Modified Dosage for Moderate Acute Malnutrition (MODAM-MAM)

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 fixed-dose regimen of RUSF for children with MAM.

CONDITIONS

Official Title

Modified Dosage for Moderate Acute Malnutrition (MODAM-MAM)

Who Can Participate

Age: 6Months - 59Months
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 6 and 59 months
  • Reside in the local health post area with no plans to move within the next year
  • Have uncomplicated moderate acute malnutrition without signs of severe illness
  • Pass an appetite test at enrollment
  • Consent given by mother, father, or primary caregiver for study participation
  • Mid-upper arm circumference between 115 mm and 124 mm without nutritional edema
  • Weight-for-height Z-score between -2 and -3
Not Eligible

You will not qualify if you...

  • Presence of complicated acute malnutrition with severe illness requiring hospitalization or specialized care, including hypothermia, high fever, hypoglycemia, lethargy, moderate to severe dehydration, shock, or other serious medical complications
  • Treatment for acute malnutrition as inpatient or outpatient within the past 3 months
  • Known chronic medical illnesses such as severe cerebral palsy, unrepaired congenital heart disease, Down syndrome, hydrocephalus, unrepaired cleft lip or palate, or other conditions affecting feeding ability

AI-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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