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Clinical Trial Details — Status: Withdrawn

Administrative data

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Status Withdrawn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

Study information

Verified date January 2014
Source Washington University School of Medicine
Contact n/a
Is FDA regulated No
Health authority Malawi: College of Medicine Research and Ethics Committee
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Malawi St. Louis Nutrition Project Blantyre

Sponsors (2)

Lead Sponsor Collaborator
Washington University School of Medicine University of Malawi College of Medicine

Country where clinical trial is conducted

Malawi, 

Outcome

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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