Status:
COMPLETED
Omega 3 Fish Oil Supplements vs. Placebo for Patients With Non-alcoholic Steatohepatitis (NASH)
Lead Sponsor:
University of Virginia
Collaborating Sponsors:
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Non-alcoholic Steatohepatitis
Fatty Liver
Eligibility:
All Genders
21+ years
Phase:
PHASE2
PHASE3
Brief Summary
Nonalcoholic steatohepatitis (NASH) occurs in 2-3% of the US population and carries a 15-20% chance of progression to cirrhosis. It is closely associated with obesity, hyperlipidemia and insulin resis...
Eligibility Criteria
Inclusion
- NASH with NAS (NASH Activity Score) of \>4 evident on a biopsy performed within 6 months of enrollment.
- Age 21 years or older.
- BMI 25 or greater.
- Ability to provide informed consent.
Exclusion
- Cirrhosis evident clinically or on biopsy.
- Secondary forms of NASH such as that seen with bariatric surgery or medication induced from such medications as methotrexate, amiodarone, tamoxifen, corticosteroids.
- Current or past history of diabetes or hyperlipidemia requiring specific drug therapy (see below).
- Current use of a weight loss medicine, such as a 'fat-burner' or similar agent
- Alcohol consumption \> 30 g/day, currently or for more than 3 consecutive months within 5 years.
- Other liver disease (hepatitis C,B, Wilson's, autoimmune, ct-1-antitrypsin and hemochromatosis or HIV
- Pregnancy or unwillingness to use an effective form of birth control for women of child bearing years.
- Renal insufficiency (creatinine \> 2), symptomatic coronary, peripheral or neurovascular disease, symptomatic heart failure or advanced respiratory disease requiring oxygen therapy.
- Inability to provide informed consent.
- Any condition in the opinion of the primary investigator that would contraindicate the patient's participation.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00681408
Start Date
March 1 2007
End Date
August 1 2010
Last Update
May 29 2015
Active Locations (1)
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1
University of Virginia School of Medicine
Charlottesville, Virginia, United States, 22908