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Package of Interventions After Recovering From Moderate Acute Malnutrition

Primary Purpose

Malnutrition

Status
Completed
Phase
Not Applicable
Locations
Malawi
Study Type
Interventional
Intervention
Lipid Nutrient Supplement
Sulfadoxine-pyrimethamine
Albendazole
Zinc
Insecticide-treated bednet
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malnutrition focused on measuring Moderate Acute Malnutrition

Eligibility Criteria

6 Months - 59 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Louis Nutrition Project

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

No Intervention

Package of interventions

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 21, 2015
Last Updated
November 9, 2016
Sponsor
Washington University School of Medicine
Collaborators
University of Malawi
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1. Study Identification

Unique Protocol Identification Number
NCT02351687
Brief Title
Package of Interventions After Recovering From Moderate Acute Malnutrition
Official Title
Randomized Controlled Trial of the Impact of Offering a Nutrition and Health Intervention to Children Recovered From Moderate Acute Malnutrition
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
University of Malawi

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition
Keywords
Moderate Acute Malnutrition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
1499 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No Intervention
Arm Type
No Intervention
Arm Description
No specific intervention given after recovery from moderate acute malnutrition.
Arm Title
Package of interventions
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Lipid Nutrient Supplement
Intervention Type
Drug
Intervention Name(s)
Sulfadoxine-pyrimethamine
Intervention Type
Drug
Intervention Name(s)
Albendazole
Intervention Type
Drug
Intervention Name(s)
Zinc
Intervention Type
Other
Intervention Name(s)
Insecticide-treated bednet
Primary Outcome Measure Information:
Title
Number of children who remain well-nourished (Defined as mid-upper arm circumference (MUAC) > 12.5 cm and without edema)
Description
Defined as mid-upper arm circumference (MUAC) > 12.5 cm and without edema
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
59 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark J Manary, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Louis Nutrition Project
City
Blantyre
Country
Malawi

12. IPD Sharing Statement

Citations:
PubMed Identifier
29726948
Citation
Stobaugh HC, Rogers BL, Rosenberg IH, Webb P, Maleta KM, Manary MJ, Trehan I. Children with Poor Linear Growth Are at Risk for Repeated Relapse to Wasting after Recovery from Moderate Acute Malnutrition. J Nutr. 2018 Jun 1;148(6):974-979. doi: 10.1093/jn/nxy033.
Results Reference
derived
PubMed Identifier
28615258
Citation
Stobaugh HC, Bollinger LB, Adams SE, Crocker AH, Grise JB, Kennedy JA, Thakwalakwa C, Maleta KM, Dietzen DJ, Manary MJ, Trehan I. Effect of a package of health and nutrition services on sustained recovery in children after moderate acute malnutrition and factors related to sustaining recovery: a cluster-randomized trial. Am J Clin Nutr. 2017 Aug;106(2):657-666. doi: 10.3945/ajcn.116.149799. Epub 2017 Jun 14.
Results Reference
derived

Learn more about this trial

Package of Interventions After Recovering From Moderate Acute Malnutrition

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