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Effectiveness of Oral Albendazole in the Treatment of Severe Acute Malnutrition

This study has been withdrawn prior to enrollment.
(not funded)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01395381
First Posted: July 15, 2011
Last Update Posted: January 28, 2014
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.
Collaborator:
University of Malawi College of Medicine
Information provided by (Responsible Party):
Washington University School of Medicine
  Purpose
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 Intervention
Kwashiorkor Marasmus Drug: Placebo Drug: Albendazole

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

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

  • mortality [ Time Frame: 12 weeks ]

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

  • height and weight gain [ Time Frame: 6 months ]

Enrollment: 0
Study Start Date: January 2013
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
placebo given once
Experimental: Albendazole Drug: Albendazole
single dose albendazole given at the time of enrollment

  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01395381


Locations
Malawi
St. Louis Nutrition Project
Blantyre, Malawi
Sponsors and Collaborators
Washington University School of Medicine
University of Malawi College of Medicine
Investigators
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
  More Information

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01395381     History of Changes
Other Study ID Numbers: MJM-albendazole
First Submitted: July 1, 2011
First Posted: July 15, 2011
Last Update Posted: January 28, 2014
Last Verified: January 2014

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