Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on November 27, 2014