Status:
TERMINATED
Fish Oil and Diet for the Treatment of Non-Alcoholic Steatohepatitis (NASH)
Lead Sponsor:
University of Illinois at Chicago
Conditions:
Nonalcoholic Steatohepatitis (NASH)
Hepatic Steatosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 (Lo...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00845845
Start Date
March 1 2006
End Date
October 1 2010
Last Update
July 24 2013
Active Locations (1)
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1
The University of Illinois Chicago
Chicago, Illinois, United States, 60612