Effectiveness of Oral Albendazole in the Treatment of Severe Acute Malnutrition

Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Benefit of Antihelminthic Therapy in the Community-Based Treatment of Severe Acute Malnutrition in Malawian Children

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01395381

Enrollment

Registered

2011-07-15

Start date

2013-01-31

Completion date

Unknown

Last updated

2014-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kwashiorkor, Marasmus

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.

Interventions

DRUGPlacebo

placebo given once

DRUGAlbendazole

single dose albendazole given at the time of enrollment

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

6 Months to 59 Months

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
nutritional recovery	12 weeks	Weight-for-Height Z-score (WHZ) \> -2 without bipedal pitting edema
mortality	12 weeks	—

Secondary

Measure	Time frame	Description
malnutrition relapse	6 months	acute malnutrition, either moderate (WHZ \< -2) or severe (WHZ \< -3 and/or bipedal pitting edema)
height and weight gain	6 months	—

Countries

Malawi

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026