Safety efficacy, and cost-effectivness of modified doses of ready-to-use therapeutic and supplementary foods for the treatment of acute malnutrition among children 6-59 months of age in Ethiopia: An individually randomized controlled clinical trial

Action Against Hunger0 sites8,400 target enrollmentSeptember 6, 2023

Overview

No summary available.

Registry

who.int

Start Date

September 6, 2023

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

•SAM Cohort:
•1\. Age 6\-59 months
•2\. 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
•3\. Uncomplicated severe acute malnutrition, as defined by no signs of severe illness that would require referral to inpatient facility
•4\. Pass appetite test conducted at the time of enrollment
•5\. Consent for randomization into the study given by mother, father, and/or other primary caregiver
•6\. Mid\-upper arm circumference less than 115 mm and/or nutritional edema
•7\. Weight\-for\-height Z\-score (WHZ) less than \-3 (will not count towards planned sample size)
•MAM Cohort:
•1\. Age 6\-59 months

•All Cohorts:
•1\. 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
•2\. Treatment for acute malnutrition, either as an inpatient or outpatient, within the past 3 months
•3\. 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.