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NCT01285362 · ClinicalTrials.gov registry record · NA
Fish Oil and Nonalcoholic Fatty Liver Disease (NAFLD) Study
A NA study of Non-alcoholic Fatty Liver Disease, sponsored by Columbia University.
- Completed
- Registry status
- NA
- Development phase
- 8
- Enrollment target
- 1
- Study location
NCT01285362 is a NA study of Non-alcoholic Fatty Liver Disease that has completed, run by Columbia University. The registered enrollment target is 8 participants, below the 190-participant average among 50 other Non-alcoholic Fatty Liver Disease trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01285362, a NA study of Non-alcoholic Fatty Liver Disease, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- NA
- Development phase
- 8 participants
- Enrollment target
- 1
- Study location
Study Summary
Over the past 30 years, the prevalence of childhood obesity in the United States has tripled from 5% to 15%. Major consequences of obesity include insulin resistance, type- 2 diabetes, cardiovascular disease and nonalcoholic fatty liver disease (NAFLD). The liver pathology encompasses a range from isolated fatty liver to advanced fibrosis, cirrhosis and end-stage liver disease. Weight loss, particularly if gradual, may lead to improvement in liver histology. Unfortunately, few patients in the pediatric population are willing to follow these recommendations and achieve weight loss. Medical treatment directed specifically at the liver disease has only recently been investigated and approved in patients with NAFLD. The beneficial effects of fish oil are attributed to its high concentrations of n - 3 fatty acids: eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), which are major regulators of pathways that participate in decreased production and break down of triglycerides and fatty acids in the liver. The investigators hypothesize that children with obesity related NAFLD will normalize elevated liver enzymes, plasma lipid levels, and attenuate insulin resistance with supplements of n-3 fatty acids. If this hypothesis is proven true, then fish oil could be used to treat NAFLD and to prevent the deterioration of fatty liver into end-stage liver disease.
Conditions Studied
Interventions
- DRUG Fish Oil Supplementation
- DRUG Placebo Supplementation
Study Locations (1)
New York
- Irving Clinical Research Center (GCRC) at Columbia University Medical Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2013-03 |
| Est. Completion | 2014-09 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01285362
The ClinicalTrials.gov registry entry for NCT01285362 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 190-participant average among 50 other Non-alcoholic Fatty Liver Disease trials with a reported enrollment target (96% lower). The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Non-alcoholic Fatty Liver Disease appearing as the primary indexed condition, and to 2 interventions - of which Fish Oil Supplementation is the first listed.
NCT01285362 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT01285362 about?
NCT01285362 is a clinical study titled "Fish Oil and Nonalcoholic Fatty Liver Disease (NAFLD) Study". Over the past 30 years, the prevalence of childhood obesity in the United States has tripled from 5% to 15%. Major consequences of obesity include insulin resistance, type- 2 diabetes, cardiovascular disease and nonalcoholic fatty liver disease (NAFLD). The liver pathology encompasses a range from i...
What is the current status of trial NCT01285362?
This trial is currently completed. It is a NA study. The enrollment target is 8 participants. The study started on 2013-03. Estimated completion is 2014-09.
What conditions does trial NCT01285362 study?
This clinical trial studies the following conditions: Non-alcoholic Fatty Liver Disease.
What interventions are being tested in trial NCT01285362?
The interventions under investigation include: Fish Oil Supplementation (DRUG), Placebo Supplementation (DRUG).
Who is sponsoring clinical trial NCT01285362?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01285362 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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