NCT01395381

Brief Summary

The benefit of anti-worm therapy as part of the case management of severe acute malnutrition (SAM) in the outpatient setting has not previously been studied. This study will compare recovery rates of children with SAM treated in the community with locally-produced ready-to-use therapeutic food (RUTF) with and without prescribed albendazole as part of their case management.

Trial Health

35
At Risk

Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2011

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 15, 2011

Completed
1.5 years until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Last Updated

January 28, 2014

Status Verified

January 1, 2014

Enrollment Period

1 year

First QC Date

July 1, 2011

Last Update Submit

January 24, 2014

Conditions

KwashiorkorMarasmus

Outcome Measures

Primary Outcomes (2)

  • nutritional recovery

    Weight-for-Height Z-score (WHZ) \> -2 without bipedal pitting edema

    12 weeks

  • mortality

    12 weeks

Secondary Outcomes (2)

  • malnutrition relapse

    6 months

  • height and weight gain

    6 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Albendazole

EXPERIMENTAL
Drug: Albendazole

Interventions

PlaceboDRUG

placebo given once

Placebo
AlbendazoleDRUG

single dose albendazole given at the time of enrollment

Albendazole

Eligibility Criteria

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

You may qualify if:

  • months old
  • Kwashiorkor and/or Marasmus
  • Qualified for home-based therapeutic feeding with RUTF

You may not qualify if:

  • Obvious congenital or other malformation that makes child a poor candidate for feeding with RUTF
  • Unable to consume test-dose of RUTF in clinic
  • Parent refusal to participate and return for follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Louis Nutrition Project

Blantyre, Malawi

Location

MeSH Terms

Conditions

KwashiorkorProtein-Energy Malnutrition

Interventions

Albendazole

Condition Hierarchy (Ancestors)

Severe Acute MalnutritionMalnutritionNutrition DisordersNutritional and Metabolic DiseasesProtein DeficiencyDeficiency Diseases

Intervention Hierarchy (Ancestors)

CarbamatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Mark J Manary, MD

    University of Malawi

    PRINCIPAL INVESTIGATOR

  • Kenneth Maleta, MBBS PhD

    University of Malawi

    PRINCIPAL INVESTIGATOR

  • Indi Trehan, MD MPH DTM&H

    University of Malawi

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2011

First Posted

July 15, 2011

Study Start

January 1, 2013

Primary Completion

January 1, 2014

Last Updated

January 28, 2014

Record last verified: 2014-01

Locations

MA(1)