Clinical trial NCT00845845: Fish Oil and Diet for the Treatment of Non-Alcoholic Steatohepatitis (NASH)
Official title: Fish Oil and Diet for the Treatment of Non-Alcoholic Steatohepatitis (NASH)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Nonalcoholic Steatohepatitis (NASH)
Hepatic Steatosis
Keywords: Non-alcoholic steatohepatitis
Omega-3 fatty acids
MRI
NASH
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
First posted: 2009-02-18
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 (Lovaza) for the treatment of nonalcoholic steatohepatitis (NASH).


Eligibility 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.

Primary outcomes:
measure: Omega-3 Fatty Acid Supplementation and Its Effect on Hepatic Steatosis and Other Factors Associated With the Development of Nonalcoholic Steatohepatitis (NASH)
timeFrame: 24 weeks
Secondary outcomes:
measure: Magnetic Resonance Imaging (MRI) as an Assessment of Hepatic Steatosis in Patients With Biopsy-proven Nonalcoholic Steatohepatitis (NASH)
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Illinois Chicago
state: Illinois
Study officials:
affiliation: University of Illinois Chicago
name: Scott Cotler, M.D.
role: PRINCIPAL_INVESTIGATOR
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