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

Study Overview
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Brief Summary
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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).

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

Conditions
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Hepatic Steatosis, Nonalcoholic Steatohepatitis (NASH)

Intervention / Treatment
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* Drug: Omega-3-acid ethyl esters (Lovaza)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Omega-3-acid ethyl esters (Lovaza)<br>Participants receive 4 milligrams (mg) daily of omega-3-acid ethyl esters (Lovaza) and dietary counseling for 24 weeks | Drug: Omega-3-acid ethyl esters (Lovaza)<br>* 4 milligrams daily omega-3-acid ethyl esters (Lovaza) with dietary counseling for 24 weeks.<br>* Other names: Lovaza;|
| Placebo Comparator: Placebo<br>Participants receive daily placebo and dietary counseling for 24 weeks | Drug: Placebo<br>* Daily placebo with dietary counseling for 24 weeks.<br>* Other names: Sugar pill;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Omega-3 Fatty Acid Supplementation and Its Effect on Hepatic Steatosis and Other Factors Associated With the Development of Nonalcoholic Steatohepatitis (NASH) |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Magnetic Resonance Imaging (MRI) as an Assessment of Hepatic Steatosis in Patients With Biopsy-proven Nonalcoholic Steatohepatitis (NASH) |  | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-alcoholic steatohepatitis, Omega-3 fatty acids, MRI, NASH