Effectiveness of Oral Albendazole in the Treatment of Severe Acute Malnutrition
Primary Purpose
Kwashiorkor, Marasmus
Status
Withdrawn
Phase
Not Applicable
Locations
Malawi
Study Type
Interventional
Intervention
Placebo
Albendazole
Sponsored by
About this trial
This is an interventional treatment trial for Kwashiorkor
Eligibility 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
Sites / Locations
- St. Louis Nutrition Project
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Albendazole
Arm Description
Outcomes
Primary Outcome Measures
nutritional recovery
Weight-for-Height Z-score (WHZ) > -2 without bipedal pitting edema
mortality
Secondary Outcome Measures
malnutrition relapse
acute malnutrition, either moderate (WHZ < -2) or severe (WHZ < -3 and/or bipedal pitting edema)
height and weight gain
Full Information
NCT ID
NCT01395381
First Posted
July 1, 2011
Last Updated
January 24, 2014
Sponsor
Washington University School of Medicine
Collaborators
Kamuzu University of Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01395381
Brief Title
Effectiveness of Oral Albendazole in the Treatment of Severe Acute Malnutrition
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Withdrawn
Why Stopped
not funded
Study Start Date
January 2013 (undefined)
Primary Completion Date
January 2014 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
Kamuzu University of Health Sciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kwashiorkor, Marasmus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Albendazole
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo given once
Intervention Type
Drug
Intervention Name(s)
Albendazole
Intervention Description
single dose albendazole given at the time of enrollment
Primary Outcome Measure Information:
Title
nutritional recovery
Description
Weight-for-Height Z-score (WHZ) > -2 without bipedal pitting edema
Time Frame
12 weeks
Title
mortality
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
malnutrition relapse
Description
acute malnutrition, either moderate (WHZ < -2) or severe (WHZ < -3 and/or bipedal pitting edema)
Time Frame
6 months
Title
height and weight gain
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
59 Months
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark J Manary, MD
Organizational Affiliation
University of Malawi
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kenneth Maleta, MBBS PhD
Organizational Affiliation
University of Malawi
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Indi Trehan, MD MPH DTM&H
Organizational Affiliation
University of Malawi
Official's Role
Study Director
Facility Information:
Facility Name
St. Louis Nutrition Project
City
Blantyre
Country
Malawi
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of Oral Albendazole in the Treatment of Severe Acute Malnutrition
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