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

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ClinicalTrials.gov Identifier: NCT00845845
Recruitment Status : Terminated (Terminated due to low enrollment.)
First Posted : February 18, 2009
Results First Posted : July 24, 2013
Last Update Posted : July 24, 2013
Sponsor:
Information provided by (Responsible Party):
Scott Cotler, MD, University of Illinois at Chicago

February 17, 2009
February 18, 2009
February 6, 2013
July 24, 2013
July 24, 2013
March 2006
October 2010   (Final data collection date for primary outcome measure)
Omega-3 Fatty Acid Supplementation and Its Effect on Hepatic Steatosis and Other Factors Associated With the Development of Nonalcoholic Steatohepatitis (NASH) [ Time Frame: 24 weeks ]
  • Evidence that omega-3 fatty acid supplementation decreases hepatic steatosis and reduces factors associated with the development of NASH [ Time Frame: 24 weeks ]
  • Evidence that MRI quantifies hepatic steatosis in patients with biopsy-proven NASH [ Time Frame: 24 weeks ]
Complete list of historical versions of study NCT00845845 on ClinicalTrials.gov Archive Site
Magnetic Resonance Imaging (MRI) as an Assessment of Hepatic Steatosis in Patients With Biopsy-proven Nonalcoholic Steatohepatitis (NASH) [ Time Frame: 24 weeks ]
Not Provided
Not Provided
Not Provided
 
Fish Oil and Diet for the Treatment of Non-Alcoholic Steatohepatitis (NASH)
Fish Oil and Diet for the Treatment of Non-Alcoholic Steatohepatitis (NASH)
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).
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Nonalcoholic Steatohepatitis (NASH)
  • Hepatic Steatosis
  • Drug: Omega-3-acid ethyl esters (Lovaza)
    4 milligrams daily omega-3-acid ethyl esters (Lovaza) with dietary counseling for 24 weeks.
    Other Name: Lovaza
  • Drug: Placebo
    Daily placebo with dietary counseling for 24 weeks.
    Other Name: Sugar pill
  • Active Comparator: Omega-3-acid ethyl esters (Lovaza)
    Participants receive 4 milligrams (mg) daily of omega-3-acid ethyl esters (Lovaza) and dietary counseling for 24 weeks
    Intervention: Drug: Omega-3-acid ethyl esters (Lovaza)
  • Placebo Comparator: Placebo
    Participants receive daily placebo and dietary counseling for 24 weeks
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
12
24
October 2010
October 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00845845
2003-0601
No
Not Provided
Not Provided
Scott Cotler, MD, University of Illinois at Chicago
University of Illinois at Chicago
Not Provided
Principal Investigator: Scott Cotler, M.D. University of Illinois Chicago
University of Illinois at Chicago
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP