Clinical Trial: Effectiveness of Oral Albendazole in the Treatment of Severe Acute Malnutrition

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

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

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.

Detailed Summary:
Sponsor: Washington University School of Medicine

Current Primary Outcome:

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

Original Primary Outcome:

• nutritional recovery [ Time Frame: 12 weeks ]
  WHZ > -2 without bipedal pitting edema
• mortality [ Time Frame: 12 weeks ]

Current Secondary Outcome:

• 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 ]

Original Secondary Outcome: Same as current

Information By: Washington University School of Medicine

Dates:
Date Received: July 1, 2011
Date Started: January 2013
Date Completion:
Last Updated: January 24, 2014
Last Verified: January 2014