Back to resultsEffectiveness of High-dose Zinc Therapy and Albendazole in the Treatment of Environmental Enteropathy
Primary Purpose
Enteropathy
Status
Completed
Phase
Not Applicable
Locations
Malawi
Study Type
Interventional
Intervention
Albendazole
Placebo
High-dose Zinc
Sponsored by
About this trial
This is an interventional treatment trial for Enteropathy
Eligibility Criteria
Inclusion Criteria:
- 1-3 years of age
- Lives in study villages
Exclusion Criteria:
- Unable to drink 100 mL of sugar water
- Demonstrating evidence of severe acute malnutrition, WHZ < or = -3, presence of bi-pedal pitting edema
- Apparent need for acute medical treatment for an illness or injury
- Parent refusal to participate and return for 7-week follow-up
Sites / Locations
- Saint Louis Nutrition Project
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Zinc therapy
Albendazole
Placebo
Arm Description
High-dose zinc, equivalent 20 mg elemental zinc, to be given once per day for 14 days
Albendazole to be given once on the day of enrollment. Placebo will then be given for 13 days following.
Placebo will be given for 14 days
Outcomes
Primary Outcome Measures
Changes in urine lactulose:mannitol (L:M) ratio following therapy course.
Secondary Outcome Measures
Change in blood endoCAb
Change in fecal calprotectin mRNA
Full Information
NCT ID
NCT01440608
First Posted
September 22, 2011
Last Updated
March 2, 2012
Sponsor
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT01440608
Brief Title
Effectiveness of High-dose Zinc Therapy and Albendazole in the Treatment of Environmental Enteropathy
Official Title
Randomized, Double-blind, Placebo-controlled Trial Evaluating the Impact of High-dose Zinc Therapy and Albendazole in the Treatment of Sub-clinical Environmental Enteropathy in Rural Malawian Children
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to investigate the therapeutic effectiveness of high-dose zinc therapy and de-worming albendazole as separate interventions in restoring normal gut absorptive and immunological function as measured by the dual sugar permeability test and additional biomarkers in 1-3 year old rural Malawian children at high risk for Environmental Enteropathy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Enteropathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
225 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Zinc therapy
Arm Type
Experimental
Arm Description
High-dose zinc, equivalent 20 mg elemental zinc, to be given once per day for 14 days
Arm Title
Albendazole
Arm Type
Experimental
Arm Description
Albendazole to be given once on the day of enrollment. Placebo will then be given for 13 days following.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo will be given for 14 days
Intervention Type
Drug
Intervention Name(s)
Albendazole
Intervention Description
Pill form, to be given once, 200 mg dosage for children 1-2 years of age, 400 mg dosage for children 2-3 years of age
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Pill form, 400 mg dose to be given once per day for 14 days in Placebo arm and 13 days in Albendazole arm following one dose of Albendazole.
Intervention Type
Dietary Supplement
Intervention Name(s)
High-dose Zinc
Intervention Description
Pill form, equivalent to 20 mg elemental zinc, to be given once per day for 14 days
Primary Outcome Measure Information:
Title
Changes in urine lactulose:mannitol (L:M) ratio following therapy course.
Time Frame
4 weeks, 7 weeks
Secondary Outcome Measure Information:
Title
Change in blood endoCAb
Time Frame
7 weeks
Title
Change in fecal calprotectin mRNA
Time Frame
4 weeks, 7 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
1-3 years of age
Lives in study villages
Exclusion Criteria:
Unable to drink 100 mL of sugar water
Demonstrating evidence of severe acute malnutrition, WHZ < or = -3, presence of bi-pedal pitting edema
Apparent need for acute medical treatment for an illness or injury
Parent refusal to participate and return for 7-week follow-up
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark J Manary, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saint Louis Nutrition Project
City
Blantyre
Country
Malawi
12. IPD Sharing Statement
Citations:
PubMed Identifier
24462483
Citation
Ryan KN, Stephenson KB, Trehan I, Shulman RJ, Thakwalakwa C, Murray E, Maleta K, Manary MJ. Zinc or albendazole attenuates the progression of environmental enteropathy: a randomized controlled trial. Clin Gastroenterol Hepatol. 2014 Sep;12(9):1507-13.e1. doi: 10.1016/j.cgh.2014.01.024. Epub 2014 Jan 22.
Results Reference
derived
Learn more about this trial
Effectiveness of High-dose Zinc Therapy and Albendazole in the Treatment of Environmental Enteropathy
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