Effectiveness of Oral Albendazole in the Treatment of Severe Acute Malnutrition

This study has been withdrawn prior to enrollment.
(not funded)
Sponsor:
Collaborator:
University of Malawi College of Medicine
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01395381
First received: July 1, 2011
Last updated: January 24, 2014
Last verified: January 2014
  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: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
    Weight-for-Height Z-score (WHZ) > -2 without bipedal pitting edema

  • mortality [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • malnutrition relapse [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    acute malnutrition, either moderate (WHZ < -2) or severe (WHZ < -3 and/or bipedal pitting edema)

  • height and weight gain [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   6 Months to 59 Months
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01395381     History of Changes
Other Study ID Numbers: MJM-albendazole
Study First Received: July 1, 2011
Last Updated: January 24, 2014
Health Authority: Malawi: College of Medicine Research and Ethics Committee

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

ClinicalTrials.gov processed this record on September 18, 2014