Package of Interventions After Recovering From Moderate Acute Malnutrition

NCT ID: NCT02351687

Last Updated: 2016-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1499 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2016-06-30

Brief Summary

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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

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Conditions

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Malnutrition

Keywords

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Moderate Acute Malnutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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No Intervention

No specific intervention given after recovery from moderate acute malnutrition.

Group Type NO_INTERVENTION

No interventions assigned to this group

Package of interventions

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.

Group Type EXPERIMENTAL

Lipid Nutrient Supplement

Intervention Type DIETARY_SUPPLEMENT

Sulfadoxine-pyrimethamine

Intervention Type DRUG

Albendazole

Intervention Type DRUG

Zinc

Intervention Type DRUG

Insecticide-treated bednet

Intervention Type OTHER

Interventions

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Lipid Nutrient Supplement

Intervention Type DIETARY_SUPPLEMENT

Sulfadoxine-pyrimethamine

Intervention Type DRUG

Albendazole

Intervention Type DRUG

Zinc

Intervention Type DRUG

Insecticide-treated bednet

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

6 Months

Maximum Eligible Age

59 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Malawi

OTHER

Sponsor Role collaborator

Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark J Manary, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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St. Louis Nutrition Project

Blantyre, , Malawi

Site Status

Countries

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Malawi

References

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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.

Reference Type DERIVED
PMID: 29726948 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28615258 (View on PubMed)

Other Identifiers

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MFU2014

Identifier Type: -

Identifier Source: org_study_id