Modified Dosage for Moderate Acute Malnutrition (MODAM-MAM)
ConditionModerate Acute Malnutrition
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-59
SponsorAction Against Hunger USA
About this trial
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.
Eligibility criteria
Qualifiers
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 moderate 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
Disqualifiers
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
Trial design
Treatments tested in this trial
- ready-to-use supplementary food (RUSF)
- ready-to-use therapeutic food (RUTF)
Treatment groups
2,400 Participants
are divided into 3 treatment groupsSponsors and collaborators
Action Against Hunger USA
Lead sponsor
University of Washington
Collaborator
Ethiopian Public Health Institute
Collaborator
Source ClinicalTrials.gov