- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01440608
Effectiveness of High-dose Zinc Therapy and Albendazole in the Treatment of Environmental Enteropathy
March 2, 2012 updated by: Washington University School of Medicine
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
225
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Blantyre, Malawi
- Saint Louis Nutrition Project
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 3 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Zinc therapy
High-dose zinc, equivalent 20 mg elemental zinc, to be given once per day for 14 days
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Pill form, equivalent to 20 mg elemental zinc, to be given once per day for 14 days
|
Experimental: Albendazole
Albendazole to be given once on the day of enrollment.
Placebo will then be given for 13 days following.
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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
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Placebo Comparator: Placebo
Placebo will be given for 14 days
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changes in urine lactulose:mannitol (L:M) ratio following therapy course.
Time Frame: 4 weeks, 7 weeks
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4 weeks, 7 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in blood endoCAb
Time Frame: 7 weeks
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7 weeks
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Change in fecal calprotectin mRNA
Time Frame: 4 weeks, 7 weeks
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4 weeks, 7 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2011
Primary Completion (Actual)
December 1, 2011
Study Completion (Actual)
December 1, 2011
Study Registration Dates
First Submitted
September 22, 2011
First Submitted That Met QC Criteria
September 23, 2011
First Posted (Estimate)
September 26, 2011
Study Record Updates
Last Update Posted (Estimate)
March 6, 2012
Last Update Submitted That Met QC Criteria
March 2, 2012
Last Verified
March 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Gastrointestinal Diseases
- Intestinal Diseases
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antiprotozoal Agents
- Antiparasitic Agents
- Anthelmintics
- Antiplatyhelmintic Agents
- Anticestodal Agents
- Albendazole
Other Study ID Numbers
- MJM-zincalbendazole
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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