Back to resultsCombined Package of Interventions for Environmental Enteropathy
Primary Purpose
Environmental Enteropathy
Status
Completed
Phase
Not Applicable
Locations
Malawi
Study Type
Interventional
Intervention
Albendazole
Zinc
Multiple Micronutrient Supplement
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Environmental Enteropathy
Eligibility Criteria
Inclusion Criteria:
- children residing in catchment area of Limela, Machinga District, Malawi
- aged 12-35 months
- youngest eligible child in each household
Exclusion Criteria:
- 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
Sites / Locations
- Limela Rural Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Multiple Intervention Arm
Placebo
Arm Description
single dose albendazole, two weeks of zinc, 24 weeks of multiple micronutrients
three placebos
Outcomes
Primary Outcome Measures
Dual Sugar Absorption Test
lactulose-mannitol ratio in urine
Dual Sugar Absorption Test
lactulose-mannitol ratio in urine
Secondary Outcome Measures
Lactulose Excretion
percentage of ingested lactulose excreted in urine
Lactulose Excretion
percentage of ingested lactulose excreted in urine
Mannitol Excretion
percentage of ingested mannitol excreted in urine
Mannitol Excretion
percentage of ingested mannitol excreted in urine
Full Information
NCT ID
NCT02253095
First Posted
September 26, 2014
Last Updated
June 2, 2015
Sponsor
Washington University School of Medicine
Collaborators
University of Malawi
1. Study Identification
Unique Protocol Identification Number
NCT02253095
Brief Title
Combined Package of Interventions for Environmental Enteropathy
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
University of Malawi
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Environmental Enteropathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
253 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Multiple Intervention Arm
Arm Type
Experimental
Arm Description
single dose albendazole, two weeks of zinc, 24 weeks of multiple micronutrients
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
three placebos
Intervention Type
Drug
Intervention Name(s)
Albendazole
Intervention Type
Dietary Supplement
Intervention Name(s)
Zinc
Intervention Type
Dietary Supplement
Intervention Name(s)
Multiple Micronutrient Supplement
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Dual Sugar Absorption Test
Description
lactulose-mannitol ratio in urine
Time Frame
12 weeks
Title
Dual Sugar Absorption Test
Description
lactulose-mannitol ratio in urine
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Lactulose Excretion
Description
percentage of ingested lactulose excreted in urine
Time Frame
12 weeks
Title
Lactulose Excretion
Description
percentage of ingested lactulose excreted in urine
Time Frame
24 weeks
Title
Mannitol Excretion
Description
percentage of ingested mannitol excreted in urine
Time Frame
12 weeks
Title
Mannitol Excretion
Description
percentage of ingested mannitol excreted in urine
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
35 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
children residing in catchment area of Limela, Machinga District, Malawi
aged 12-35 months
youngest eligible child in each household
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark J Manary, MD
Organizational Affiliation
Washington University in St. Louis; University of Malawi
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chrissie Thakwalakwa, PhD
Organizational Affiliation
University of Malawi
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Indi Trehan, MD MPH DTM&H
Organizational Affiliation
Washington University in St. Louis; University of Malawi
Official's Role
Study Director
Facility Information:
Facility Name
Limela Rural Site
City
Limela
State/Province
Machinga Distric
Country
Malawi
12. IPD Sharing Statement
Citations:
PubMed Identifier
27807040
Citation
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.
Results Reference
derived
Learn more about this trial
Combined Package of Interventions for Environmental Enteropathy
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