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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: Completed NA study of Non-alcoholic Fatty Liver Disease, sponsored by Columbia University.
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 177-participant average among 57 other Non-alcoholic Fatty Liver Disease trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To evaluate the number of participants (young adults with obesity related NAFLD) that will normalize their elevated liver enzyme levels (normalized defined as having liver enzyme levels within a normal laboratory range) with supplements of fish oil (n-3 FA containing eicosapentanoic acid and docosahexaenoic acid).
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 |
What the finished NCT01285362 record still lists
NCT01285362 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 177-participant average among 57 other Non-alcoholic Fatty Liver Disease trials with a reported enrollment target (95% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT01285362's enrollment target sits among peer trials
8 58th of 57 the lowest of 57 other Non-alcoholic Fatty Liver Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-alcoholic Fatty Liver Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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