| Trial ID: | L0179 |
| Source ID: | NCT00681408
|
| Associated Drug: |
Fish Oil
|
| Title: |
Omega 3 Fish Oil Supplements vs. Placebo for Patients With Non-alcoholic Steatohepatitis (NASH)
|
| Acronym: |
--
|
| Status: |
Completed
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Non-alcoholic Steatohepatitis|Fatty Liver
|
| Interventions: |
Drug: Omega 3 Fish Oil supplements|Drug: Placebo
|
| Outcome Measures: |
The Primary endpoint will be improvement in a composite score of histological injury as measured by the NASH Activity Score (NAS).|Measurement of anthropometric indices (weight, BMI, waist circumference)|Index of cardiorespiratory fitness determined by exercise tolerance (measured by lactate threshold on an exercise treadmill)|Hepatic fat content measured by magnetic resonance imaging|Changes in fasting plasma lipids, red cell fatty acid content, changes in anti-hyperlipidemia requirements, insulin sensitivity, and markers of inflammation including tumor necrosis factor and C-reactive protein
|
| Sponsor/Collaborators: |
University of Virginia|National Center for Complementary and Integrative Health (NCCIH)
|
| Gender: |
All
|
| Age: |
21 Years and older ?? (Adult, Older Adult)
|
| Phases: |
Phase 2/Phase 3
|
| Enrollment: |
41
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Triple (Participant, Care Provider, Investigator)|Primary Purpose: Treatment
|
| Start Date: |
March 2007
|
| Completion Date: |
August 2010
|
| Results First Posted: |
--
|
| Last Update Posted: |
May 29, 2015
|
| Locations: |
University of Virginia School of Medicine, Charlottesville, Virginia, United States
|
| URL: |
https://ClinicalTrials.gov/show/NCT00681408
|
