Effectiveness of Oral Albendazole in the Treatment of Severe Acute Malnutrition

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Kwashiorkor Marasmus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

placebo given once

Albendazole

Group Type EXPERIMENTAL

Albendazole

Intervention Type DRUG

single dose albendazole given at the time of enrollment

Interventions

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Placebo

placebo given once

Intervention Type DRUG

Albendazole

single dose albendazole given at the time of enrollment

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 12-59 months old
* Kwashiorkor and/or Marasmus
* Qualified for home-based therapeutic feeding with RUTF

Exclusion Criteria

* 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

Minimum Eligible Age

6 Months

Maximum Eligible Age

59 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No