Fish Oil and Diet for the Treatment of Non-Alcoholic Steatohepatitis (NASH)
Condition: Nonalcoholic Steatohepatitis (NASH); Hepatic Steatosis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Intervention: Omega-3-acid ethyl esters (Lovaza); Placebo
Intervention description: 4 milligrams daily omega-3-acid ethyl esters (Lovaza) with dietary counseling for 24 weeks.; Daily placebo with dietary counseling for 24 weeks.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Non-alcoholic steatohepatitis; Omega-3 fatty acids; MRI; NASH

Summary:

      The current pilot study assesses the use of magnetic resonance imaging (MRI) to quantify
      hepatic steatosis. It will provide preliminary data regarding the use of omega-3 fatty acid
      supplementation (Lovaza) for the treatment of nonalcoholic steatohepatitis (NASH).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females at least 18 years of age.

          -  Evidence of nonalcoholic steatohepatitis (NASH) on a liver biopsy performed within six
             months of entry to this study.

          -  Laboratory parameters indicative of decompensated liver disease including:

               -  bilirubin less than 2 milligrams/decilitre (mg/dl).

               -  stable albumin within normal limits.

               -  prothrombin time less than 3 seconds prolonged.

          -  Serum creatinine less than 1.5 times the upper limit of normal.

          -  Diabetic patients must be stable on oral medication for diabetes or have had less than
             a 10 percent change in their insulin dose over the past two months.

          -  Thyroid stimulating hormone (TSH) or Free Thyroxine Index (FTI) within the normal
             range.

          -  Hepatitis C antibody negative.

          -  Hepatitis B Surface Antigen (HBsAg) seronegative.

          -  Antinuclear antibody (ANA) less than 1:320.

          -  Patient provides written informed consent.

        Exclusion Criteria:

          -  Alcohol use exceeding 10 to 29 grams per day during the past six months.

          -  Evidence of a cause of liver disease other than nonalcoholic steatohepatitis (NASH) on
             liver biopsy including: viral hepatitis, alcoholic liver disease, autoimmune
             hepatitis, hemochromatosis, Wilson's disease, alpha-1 antitrypsin deficiency, or
             recent hepatoxic drug exposure.

          -  Patients with cirrhosis.

          -  Use of medications commonly associated with nonalcoholic steatohepatitis (NASH)
             including: glucocorticoids, estrogens, tamoxifen, methotrexate, nifedipine, diltiazem,
             chloroquine, isoniazid, or amiodarone within the past six months.

          -  Use of non-steroidal antiinflammatory drugs, fibrates (fenofibrate or gemfibrozil) or
             warfarin within one month of entering the study.

          -  Uncontrolled diabetes, defined as a glycated hemoglobin (A1C) level greater than 8%.

          -  Patients with insulin-dependent diabetes.

          -  History of jejunal-ileal bypass or extensive small bowel resection.

          -  Substance abuse including, but not limited to, alcohol or intravenous and inhaled
             drugs within the past six months.

          -  Use of chemotherapy within six months of enrollment.

          -  Patients taking metformin.

          -  Thyroid abnormality in which normal thyroid function cannot be maintained by
             medication.

          -  Pregnancy, females who are breastfeeding.

          -  Solid organ transplant recipient.

          -  History of a medical condition, which could interfere with participation in and
             completion of the protocol.

          -  Use of oral supplements of Vitamin E within one month of enrollment.