Status:
RECRUITING
Modified Dosage for Severe Acute Malnutrition
Lead Sponsor:
Action Against Hunger USA
Collaborating Sponsors:
University of Washington
Ethiopian Public Health Institute
Conditions:
Severe Acute Malnutrition
Eligibility:
All Genders
6-59 years
Phase:
NA
Brief 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...
Eligibility Criteria
Inclusion
- Age 6-59 months
- Reside in the catchment area of the health post where the trial is to be conducted without plans to leave the area over the next year
- Uncomplicated severe acute malnutrition, as defined by no signs of severe illness that would require referral to inpatient facility
- Pass appetite test conducted at the time of enrollment
- Consent for randomization into the study given by mother, father, and/or other primary caregiver
- Mid-upper arm circumference less than 115 mm and/or nutritional edema
- Weight-for-height Z-score (WHZ) less than -3
Exclusion
- Complicated acute malnutrition with severe illness requiring transfer to a stabilization center or hospital for treatment. This includes, but is not limited to: a. Hypothermia b. High fever c. Signs of hypoglycemia d. Lethargy or altered mental status e. Moderate to severe dehydration f. Shock g. Other medical complications requiring hospitalization or higher-level medical evaluation
- Treatment for acute malnutrition, either as an inpatient or outpatient, within the past 3 months
- Known chronic medical illness such as severe cerebral palsy, severe congenital anomalies such as unrepaired congenital heart disease, Down syndrome, hydrocephalus, unrepaired cleft lip or palate, or other conditions that would be expected to contribute to difficulty feeding the prescribed amounts of therapeutic or supplementary food
Key Trial Info
Start Date :
September 25 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 25 2026
Estimated Enrollment :
2400 Patients enrolled
Trial Details
Trial ID
NCT06061484
Start Date
September 25 2023
End Date
September 25 2026
Last Update
July 16 2024
Active Locations (3)
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1
Sekota
Sekota, Amhara, Ethiopia
2
Teltele
Teltelē, Oromiya, Ethiopia
3
Gode
Gode, Somali, Ethiopia