Effectiveness of Oral Albendazole in the Treatment of Severe Acute Malnutrition

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01395381
Recruitment Status : Withdrawn (not funded)
First Posted : July 15, 2011
Last Update Posted : January 28, 2014
University of Malawi College of Medicine
Information provided by (Responsible Party):
Washington University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Kwashiorkor Marasmus Drug: Placebo Drug: Albendazole Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : January 2013
Estimated Primary Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition
Drug Information available for: Albendazole

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
placebo given once

Experimental: Albendazole Drug: Albendazole
single dose albendazole given at the time of enrollment

Primary Outcome Measures :
  1. nutritional recovery [ Time Frame: 12 weeks ]
    Weight-for-Height Z-score (WHZ) > -2 without bipedal pitting edema

  2. mortality [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. malnutrition relapse [ Time Frame: 6 months ]
    acute malnutrition, either moderate (WHZ < -2) or severe (WHZ < -3 and/or bipedal pitting edema)

  2. height and weight gain [ Time Frame: 6 months ]

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Ages Eligible for Study:   6 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01395381

St. Louis Nutrition Project
Blantyre, Malawi
Sponsors and Collaborators
Washington University School of Medicine
University of Malawi College of Medicine
Principal Investigator: Mark J Manary, MD University of Malawi
Principal Investigator: Kenneth Maleta, MBBS PhD University of Malawi
Study Director: Indi Trehan, MD MPH DTM&H University of Malawi

Responsible Party: Washington University School of Medicine Identifier: NCT01395381     History of Changes
Other Study ID Numbers: MJM-albendazole
First Posted: July 15, 2011    Key Record Dates
Last Update Posted: January 28, 2014
Last Verified: January 2014

Additional relevant MeSH terms:
Severe Acute Malnutrition
Protein-Energy Malnutrition
Nutrition Disorders
Protein Deficiency
Deficiency Diseases
Antiparasitic Agents
Anti-Infective Agents
Anticestodal Agents
Antiplatyhelmintic Agents
Antiprotozoal Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents