Package of Interventions After Recovering From Moderate Acute Malnutrition

Malnutrition Clinical Trial

Official title:

Randomized Controlled Trial of the Impact of Offering a Nutrition and Health Intervention to Children Recovered From Moderate Acute Malnutrition

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02351687
• Other study ID #: MFU2014
• Status: Completed
• Phase: N/A
• First received: January 21, 2015
• Last updated: November 9, 2016
• Start date: April 2014
• Est. completion date: June 2016

Study information

• Verified date: November 2016
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Malawi: College of Medicine Research and Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1499
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 59 Months

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malnutrition

Intervention

Dietary Supplement:
• Lipid Nutrient Supplement

Drug:
• Sulfadoxine-pyrimethamine

• Albendazole

• Zinc

Other:
• Insecticide-treated bednet

Locations

Country	Name	City	State
Malawi	St. Louis Nutrition Project	Blantyre

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	University of Malawi

Country where clinical trial is conducted

Malawi, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of children who remain well-nourished (Defined as mid-upper arm circumference (MUAC) > 12.5 cm and without edema)	Defined as mid-upper arm circumference (MUAC) > 12.5 cm and without edema	12 months	No