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

This study has been terminated.
(Terminated due to low enrollment.)
Sponsor:
Information provided by (Responsible Party):
Scott Cotler, MD, University of Illinois
ClinicalTrials.gov Identifier:
NCT00845845
First received: February 17, 2009
Last updated: June 18, 2013
Last verified: June 2013
  Purpose

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).


Condition Intervention Phase
Nonalcoholic Steatohepatitis (NASH)
Hepatic Steatosis
Drug: Omega-3-acid ethyl esters (Lovaza)
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Fish Oil and Diet for the Treatment of Non-Alcoholic Steatohepatitis (NASH)

Resource links provided by NLM:


Further study details as provided by University of Illinois at Chicago:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Magnetic Resonance Imaging (MRI) as an Assessment of Hepatic Steatosis in Patients With Biopsy-proven Nonalcoholic Steatohepatitis (NASH) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: March 2006
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
Placebo Comparator: Placebo
Participants receive daily placebo and dietary counseling for 24 weeks
Drug: Placebo
Daily placebo with dietary counseling for 24 weeks.
Other Name: Sugar pill

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00845845

Locations
United States, Illinois
The University of Illinois Chicago
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
University of Illinois at Chicago
Investigators
Principal Investigator: Scott Cotler, M.D. University of Illinois Chicago
  More Information

Publications:

Responsible Party: Scott Cotler, MD, Professor of Medicine, University of Illinois
ClinicalTrials.gov Identifier: NCT00845845     History of Changes
Other Study ID Numbers: 2003-0601
Study First Received: February 17, 2009
Results First Received: February 6, 2013
Last Updated: June 18, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Illinois at Chicago:
Non-alcoholic steatohepatitis
Omega-3 fatty acids
MRI
NASH

Additional relevant MeSH terms:
Fatty Liver
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 22, 2014