NCT02351687

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,499

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 30, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

November 10, 2016

Status Verified

November 1, 2016

Enrollment Period

2.2 years

First QC Date

January 21, 2015

Last Update Submit

November 9, 2016

Conditions

Malnutrition

Keywords

Moderate Acute Malnutrition

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

No Intervention

NO INTERVENTION

No specific intervention given after recovery from moderate acute malnutrition.

Package of interventions

EXPERIMENTAL

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.

Dietary Supplement: Lipid Nutrient SupplementDrug: Sulfadoxine-pyrimethamineDrug: AlbendazoleDrug: ZincOther: Insecticide-treated bednet

Interventions

Lipid Nutrient SupplementDIETARY_SUPPLEMENT
Package of interventions
Sulfadoxine-pyrimethamineDRUG
Package of interventions
AlbendazoleDRUG
Package of interventions
ZincDRUG
Package of interventions
Insecticide-treated bednetOTHER
Package of interventions

Eligibility Criteria

Age6 Months - 59 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • recovered from moderate acute malnutrition, as defined by mid-upper arm circumference (MUAC) of 11.5-12.4 cm

You may not qualify if:

  • not permanent resident in vicinity of site
  • severe chronic illness
  • receiving other supplementary food or participating in other research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Louis Nutrition Project

Blantyre, Malawi

Location

Related Publications (2)

  • 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.

    PMID: 29726948DERIVED

  • 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.

    PMID: 28615258DERIVED

MeSH Terms

Conditions

Malnutrition

Interventions

fanasil, pyrimethamine drug combinationAlbendazoleZincInsecticide-Treated Bednets

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

CarbamatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsMetals, HeavyElementsInorganic ChemicalsTransition ElementsMetalsMosquito NetsProtective DevicesEquipment and Supplies

Study Officials

  • Mark J Manary, MD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2015

First Posted

January 30, 2015

Study Start

April 1, 2014

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

November 10, 2016

Record last verified: 2016-11

Locations

MA(1)