Combined Package of Interventions for Environmental Enteropathy
NCT ID: NCT02253095
Last Updated: 2015-06-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
253 participants
INTERVENTIONAL
2014-10-31
2015-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Multiple Intervention Arm
single dose albendazole, two weeks of zinc, 24 weeks of multiple micronutrients
Albendazole
Zinc
Multiple Micronutrient Supplement
Placebo
three placebos
Placebo
Interventions
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Albendazole
Zinc
Multiple Micronutrient Supplement
Placebo
Eligibility Criteria
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Inclusion Criteria
* aged 12-35 months
* youngest eligible child in each household
Exclusion Criteria
* severe chronic illness
* children unable to drink 20 mL of dual sugar solution
* children in need of acute medical treatment for illness or injury at time of enrollment
12 Months
35 Months
ALL
Yes
Sponsors
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University of Malawi
OTHER
Washington University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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Mark J Manary, MD
Role: PRINCIPAL_INVESTIGATOR
Washington University in St. Louis; University of Malawi
Chrissie Thakwalakwa, PhD
Role: STUDY_DIRECTOR
University of Malawi
Indi Trehan, MD MPH DTM&H
Role: STUDY_DIRECTOR
Washington University in St. Louis; University of Malawi
Locations
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Limela Rural Site
Limela, Machinga Distric, Malawi
Countries
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References
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Wang AZ, Shulman RJ, Crocker AH, Thakwalakwa C, Maleta KM, Devaraj S, Manary MJ, Trehan I. A Combined Intervention of Zinc, Multiple Micronutrients, and Albendazole Does Not Ameliorate Environmental Enteric Dysfunction or Stunting in Rural Malawian Children in a Double-Blind Randomized Controlled Trial. J Nutr. 2017 Jan;147(1):97-103. doi: 10.3945/jn.116.237735. Epub 2016 Nov 2.
Other Identifiers
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EE-zinc-alb-micronut
Identifier Type: -
Identifier Source: org_study_id
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