Omega 3 Fish Oil Supplements vs. Placebo for Patients With Non-alcoholic Steatohepatitis (NASH)

Launched by UNIVERSITY OF VIRGINIA · May 20, 2008

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Eligibility criteria

• Inclusion Criteria:
• • 1. NASH with NAS (NASH Activity Score) of \>4 evident on a biopsy performed within 6 months of enrollment.
• • 2. Age 21 years or older.
• • 3. BMI 25 or greater.
• • 4. Ability to provide informed consent.
• Exclusion Criteria:
• • 1. Cirrhosis evident clinically or on biopsy.
• • 2. Secondary forms of NASH such as that seen with bariatric surgery or medication induced from such medications as methotrexate, amiodarone, tamoxifen, corticosteroids.
• • 3. Current or past history of diabetes or hyperlipidemia requiring specific drug therapy (see below).
• • 4. Current use of a weight loss medicine, such as a 'fat-burner' or similar agent
• • 5. Alcohol consumption \> 30 g/day, currently or for more than 3 consecutive months within 5 years.
• • 6. Other liver disease (hepatitis C,B, Wilson's, autoimmune, ct-1-antitrypsin and hemochromatosis or HIV
• • 7. Pregnancy or unwillingness to use an effective form of birth control for women of child bearing years.
• • 8. Renal insufficiency (creatinine \> 2), symptomatic coronary, peripheral or neurovascular disease, symptomatic heart failure or advanced respiratory disease requiring oxygen therapy.
• • 9. Inability to provide informed consent.
• • 10. Any condition in the opinion of the primary investigator that would contraindicate the patient's participation.