Modified Dosage for Severe Acute Malnutrition (MODAM-SAM)
Severe Acute Malnutrition
About this trial
This is an interventional treatment trial for Severe Acute Malnutrition
Eligibility Criteria
Inclusion Criteria: 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 (will not count towards planned sample size) Exclusion Criteria: 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Experimental
Experimental
Control Group
SAM Experimental A
SAM Experimental B
Standard weight-based dosing of Ready-to-Use Therapeutic Food (RUTF) at a dose of 150-200 kcal/kg/day
2 sachets (1000 kcal) of RUTF per day
2 sachets (1000 kcal) per day while MUAC < 115mm and/or edema and/or WHZ < -3; then decreasing to 1 sachet (500 kcal) per day while MUAC 115-124 and WHZ -2 to -3 and no edema