This trial is active, not recruiting.

Condition malnutrition
Treatments lipid nutrient supplement, sulfadoxine-pyrimethamine, albendazole, zinc, insecticide-treated bednet
Sponsor Washington University School of Medicine
Collaborator University of Malawi
Start date April 2014
End date April 2016
Trial size 1499 participants
Trial identifier NCT02351687, MFU2014


Children who recover from moderate acute malnutrition in Malawi remain at high risk for relapse or death in the year following recovery. This cluster-randomized trial will evaluate a package of affordable, safe, proven interventions specifically targeted to this population of children in an attempt to decrease their risk of relapse or death following recovery from moderate acute malnutrition. These children will be followed for a year following recovery to assess rates of relapse and mortality.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose treatment
(No Intervention)
No specific intervention given after recovery from moderate acute malnutrition.
Package of interventions given after recovery from moderate acute malnutrition -- includes lipid-nutrient supplement for 2 months, malaria chemoprophylaxis for 3 months during malaria season, an insecticide-treated bed net, a one-time albendazole treatment, and 14 days of zinc.
lipid nutrient supplement
insecticide-treated bednet

Primary Outcomes

Number of children who remain well-nourished (Defined as mid-upper arm circumference (MUAC) > 12.5 cm and without edema)
time frame: 12 months

Eligibility Criteria

Male or female participants from 6 months up to 59 months old.

Inclusion Criteria: - recovered from moderate acute malnutrition, as defined by mid-upper arm circumference (MUAC) of 11.5-12.4 cm Exclusion Criteria: - not permanent resident in vicinity of site - severe chronic illness - receiving other supplementary food or participating in other research

Additional Information

Official title Randomized Controlled Trial of the Impact of Offering a Nutrition and Health Intervention to Children Recovered From Moderate Acute Malnutrition
Principal investigator Mark J Manary, MD
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Washington University School of Medicine.