Actively Recruiting
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
Eligibility Criteria
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
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
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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
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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