Package of Interventions After Recovering From Moderate Acute Malnutrition

Not Applicable

Completed

• Conditions: Malnutrition
• Interventions: Dietary Supplement: Lipid Nutrient Supplement; Drug: Sulfadoxine-pyrimethamine; Drug: Albendazole; Drug: Zinc; Other: Insecticide-treated bednet

• Registration Number: NCT02351687
• Lead Sponsor: Washington University School of Medicine

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2015-01-21
• Study First Submitted QC: 2015-01-29
• Study First Posted: 2015-01-30
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-09
• Last Update Posted: 2016-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1499

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Package of interventions	Zinc	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.
Package of interventions	Lipid Nutrient Supplement	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.
Package of interventions	Insecticide-treated bednet	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.
Package of interventions	Sulfadoxine-pyrimethamine	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.
Package of interventions	Albendazole	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.

Primary Outcome Measures

Name	Time	Method
Number of children who remain well-nourished (Defined as mid-upper arm circumference (MUAC) > 12.5 cm and without edema)	12 months	Defined as mid-upper arm circumference (MUAC) \> 12.5 cm and without edema

Trial Locations

Locations (1)

St. Louis Nutrition Project; 🇲🇼 Blantyre, Malawi