Combined Package of Interventions for Environmental Enteropathy
Randomized, Double Blind, Placebo Controlled Trial Comparing the Impact of a Combined Package of Interventions vs Placebo in the Treatment of Sub-clinical Environmental Enteropathy in Rural Malawian Children
1 other identifier
interventional
253
1 country
1
Brief Summary
Randomized, double-blind, placebo controlled trial of a combined intervention of zinc, albendazole, and multiple micronutrients in improving environmental enteropathy in Malawian children.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2014
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 26, 2014
CompletedFirst Posted
Study publicly available on registry
October 1, 2014
CompletedStudy Start
First participant enrolled
October 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedJune 3, 2015
June 1, 2015
6 months
September 26, 2014
June 2, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
Dual Sugar Absorption Test
lactulose-mannitol ratio in urine
12 weeks
Dual Sugar Absorption Test
lactulose-mannitol ratio in urine
24 weeks
Secondary Outcomes (4)
Lactulose Excretion
12 weeks
Lactulose Excretion
24 weeks
Mannitol Excretion
12 weeks
Mannitol Excretion
24 weeks
Study Arms (2)
Multiple Intervention Arm
EXPERIMENTALsingle dose albendazole, two weeks of zinc, 24 weeks of multiple micronutrients
Placebo
PLACEBO COMPARATORthree placebos
Interventions
Eligibility Criteria
You may qualify if:
- children residing in catchment area of Limela, Machinga District, Malawi
- aged 12-35 months
- youngest eligible child in each household
You may not qualify if:
- severe acute malnutrition
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Washington University School of Medicinelead
- University of Malawicollaborator
Study Sites (1)
Limela Rural Site
Limela, Machinga Distric, Malawi
Related Publications (1)
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.
PMID: 27807040DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark J Manary, MD
Washington University in St. Louis; University of Malawi
- STUDY DIRECTOR
Chrissie Thakwalakwa, PhD
University of Malawi
- STUDY DIRECTOR
Indi Trehan, MD MPH DTM&H
Washington University in St. Louis; University of Malawi
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 26, 2014
First Posted
October 1, 2014
Study Start
October 1, 2014
Primary Completion
April 1, 2015
Study Completion
April 1, 2015
Last Updated
June 3, 2015
Record last verified: 2015-06