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

This study has been terminated.
(Terminated at the request of the sponsor due to slow enrollment.)
Sponsor:
Information provided by:
University of Illinois
ClinicalTrials.gov Identifier:
NCT00845845
First received: February 17, 2009
Last updated: July 5, 2012
Last verified: February 2009
History of Changes
  Purpose

The current pilot study assesses the use of MRI to quantify hepatic steatosis. It will provide preliminary data regarding the use of omega-3 fatty acid supplementation for the treatment of nonalcoholic steatohepatitis.


Condition Intervention
Nonalcoholic Steatohepatitis
Hepatic Steatosis
 Drug: Lovaza (omega-3 polyunsaturated fatty acids)
Drug: Placebo

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Illinois:

Primary Outcome Measures:
  • Evidence that omega-3 fatty acid supplementation decreases hepatic steatosis and reduces factors associated with the development of NASH [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Evidence that MRI quantifies hepatic steatosis in patients with biopsy-proven NASH [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: January 2007
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Subjects receive 4 mg/day of omega-3 fatty acid supplementation and dietary counseling for 24 weeks
 Drug: Lovaza (omega-3 polyunsaturated fatty acids)
4 mg/day of Lovaza (omega-3 fatty acids)
Placebo Comparator: 2
Subjects receive 4 mg/day of placebo and dietary counseling for 24 weeks
 Drug: Placebo
4 mg/day placebo

  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 NASH on a liver biopsy performed within six months of entry to this study.

  • Laboratory parameters indicative of decompensated liver disease including:

    • bilirubin < 2mg/dl.
    • stable albumin within normal limits.
    • prothrombin time < 3 seconds prolonged.
  • Serum creatinine < 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% change in their insulin dose over the past two months.
  • TSH or FTI within the normal range.
  • Hepatitis C antibody negative.
  • HBsAg seronegative.
  • ANA < 1:320.
  • Patient provides written informed consent.

Exclusion Criteria:

  • Alcohol use exceeding 10-29 g/day during the past six months.
  • Evidence of a cause of liver disease other than 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 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 hemoglobin A1C level > 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
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Scott Cotler, MD, University of Illinois
ClinicalTrials.gov Identifier: NCT00845845     History of Changes
Other Study ID Numbers: 2003-0601, UIC PAF: 2007-02135
Study First Received: February 17, 2009
Last Updated: July 5, 2012
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on June 17, 2013