Kwashiorkor Clinical Trial
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
NCT number | NCT01395381 |
Other study ID # | MJM-albendazole |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | July 1, 2011 |
Last updated | January 24, 2014 |
Start date | January 2013 |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | January 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 6 Months to 59 Months |
Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Malawi | St. Louis Nutrition Project | Blantyre |
Lead Sponsor | Collaborator |
---|---|
Washington University School of Medicine | University of Malawi College of Medicine |
Malawi,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | nutritional recovery | Weight-for-Height Z-score (WHZ) > -2 without bipedal pitting edema | 12 weeks | No |
Primary | mortality | 12 weeks | No | |
Secondary | malnutrition relapse | acute malnutrition, either moderate (WHZ < -2) or severe (WHZ < -3 and/or bipedal pitting edema) | 6 months | No |
Secondary | height and weight gain | 6 months | No |
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