Effectiveness of Oral Albendazole in the Treatment of Severe Acute Malnutrition

Washington University School of Medicine

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Conditions

Kwashiorkor Marasmus

Interventions

PlaceboDRUG

placebo given once

AlbendazoleDRUG

single dose albendazole given at the time of enrollment

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 59 Months

Medical Language ↔ Plain English

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

Locations (1)

St. Louis Nutrition Project

Blantyre, Malawi

Outcomes

Primary Outcomes

nutritional recovery

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

Time frame: 12 weeks

mortality

Time frame: 12 weeks

Secondary Outcomes

malnutrition relapse

acute malnutrition, either moderate (WHZ \< -2) or severe (WHZ \< -3 and/or bipedal pitting edema)

Time frame: 6 months

height and weight gain

Time frame: 6 months

Data from ClinicalTrials.gov

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