Fish Oil and Diet for the Treatment of Non-Alcoholic Steatohepatitis (NASH)

This is an interventional treatment trial for Nonalcoholic Steatohepatitis (NASH) focused on measuring Non-alcoholic steatohepatitis, Omega-3 fatty acids, MRI, NASH Read More

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.