- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01593033
Effectiveness of Micronutrient Supplementation and Fish Oil + Micronutrient Supplementation in the Treatment of Environmental Enteropathy
January 11, 2013 updated by: Washington University School of Medicine
Randomized, Double-blind, Placebo-controlled Trial Evaluating the Impact of Micronutrient Supplementation and Fish Oil + Micronutrient Supplementation in the Treatment of Sub-clinical Environmental Enteropathy in Rural Malawian Children
The purpose of this study is to investigate the therapeutic effectiveness of micronutrients (full RDA) and micronutrients + fish oil 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
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
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 1-3 years of age
- Lives in study villages
- Will not move in next 6 months
- Caregiver willing to give intervention daily for 6 months
Exclusion Criteria:
- Unable to drink 20 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
- Caregiver refusal to participate and return for 3 and 6 month follow-ups
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 |
---|---|
Placebo Comparator: Placebo
|
10 g sugar in granule form to be given daily for 6 months 0.9 mL palm oil to be given daily for 6 months
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Experimental: Fish oil and Micronutrient Supplementation
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0.9 mL highly purified fish oil (200 mg docosahexaenoic acid, 300 mg eicosapentaenoic acid) to be given daily for 6 months 1 RDA of all known micronutrients needed for normal child growth in powder form to be given daily for 6 months |
Experimental: Micronutrient Supplementation
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1 RDA all known micronutrients needed for normal child growth to be given daily in powder form for 6 months 0.9 mL palm oil given daily for 6 months
|
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: 3 months, 6 months
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3 months, 6 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changes in the expression of several fecal mRNAs
Time Frame: 3 months, 6 months
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3 months, 6 months
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Changes in amounts of lactulose and mannitol excreted in the urine as a percentage of the amounts ingested
Time Frame: 3 months, 6 months
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3 months, 6 months
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Change in height
Time Frame: 3 month, 6 month
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3 month, 6 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Mark J Manary, M.D., Washington University School of Medicine
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
May 1, 2012
Primary Completion (Actual)
November 1, 2012
Study Completion (Actual)
November 1, 2012
Study Registration Dates
First Submitted
May 3, 2012
First Submitted That Met QC Criteria
May 3, 2012
First Posted (Estimate)
May 7, 2012
Study Record Updates
Last Update Posted (Estimate)
January 14, 2013
Last Update Submitted That Met QC Criteria
January 11, 2013
Last Verified
January 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MJM - Fish Oil
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.
Clinical Trials on Environmental Enteropathy
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Washington University School of MedicineUniversity of MalawiCompleted
-
Tropical Gastroenterology & Nutrition Group (TROPGAN)Bill and Melinda Gates FoundationNot yet recruitingEnvironmental EnteropathyBangladesh, Pakistan, Senegal, Zambia
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Washington University School of MedicineCompletedEnvironmental EnteropathyMalawi
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Institut Pasteur de DakarBill and Melinda Gates Foundation; Aga Khan University; International Centre... and other collaboratorsNot yet recruitingEnvironmental Enteric Dysfunction | ProbioticSenegal
-
Children's Hospital Medical Center, CincinnatiUniversidade Federal do CearáCompletedDiarrhea | Malnutrition | Environmental EnteropathyBrazil
-
National Institute for Medical Research, TanzaniaLondon School of Hygiene and Tropical Medicine; University of Copenhagen; Queen...Active, not recruitingDiabetes | HIV | Environmental EnteropathyTanzania
-
Massachusetts General HospitalRecruitingInflammatory Bowel Diseases | Crohn Disease | Permeability; Increased | Inflammatory Disease | Environmental EnteropathyUnited States
-
Regeneron PharmaceuticalsActive, not recruitingCD55-deficient Protein-losing Enteropathy | CHAPLEUnited States, Thailand, Turkey
-
Regeneron PharmaceuticalsAvailableCD55-Deficient Protein-Losing Enteropathy
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Seoul National University HospitalNot yet recruitingFontan Operation | Protein-Losing Enteropathy | Camostat Mesylate
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-
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-
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Zhejiang UniversityNational Natural Science Foundation of ChinaCompletedInsulin Resistance | Type 2 DiabetesChina
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Laboratoire Régional de Nutrition HumaineCompleted
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Sunnybrook Health Sciences CentreHamilton Health Sciences CorporationCompletedCoronary Artery DiseaseCanada
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Wageningen Centre for Food SciencesSEAFOODplusCompletedArrhythmiaUnited Kingdom, Netherlands, Germany, Poland, Belgium, Austria, Czech Republic, Switzerland
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