Effectiveness of Oral Albendazole in the Treatment of Severe Acute Malnutrition

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.

Full Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: January 2014

Interventions

  • Drug: Placebo
    • placebo given once
  • Drug: Albendazole
    • single dose albendazole given at the time of enrollment

Arms, Groups and Cohorts

  • Placebo Comparator: Placebo
  • Experimental: Albendazole

Clinical Trial Outcome Measures

Primary Measures

  • nutritional recovery
    • Time Frame: 12 weeks
    • Weight-for-Height Z-score (WHZ) > -2 without bipedal pitting edema
  • mortality
    • Time Frame: 12 weeks

Secondary 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 6 Months

Maximum Age: 59 Months

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Washington University School of Medicine
  • Collaborator
    • Kamuzu University of Health Sciences
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Mark J Manary, MD, Principal Investigator, University of Malawi
    • Kenneth Maleta, MBBS PhD, Principal Investigator, University of Malawi
    • Indi Trehan, MD MPH DTM&H, Study Director, University of Malawi

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