Overview

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.