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

• Status: Terminated
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Illinois at Chicago

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.