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

June 18, 2013 updated by: Scott Cotler, MD, University of Illinois at Chicago
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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • The University of Illinois Chicago

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Sugar pill

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Magnetic Resonance Imaging (MRI) as an Assessment of Hepatic Steatosis in Patients With Biopsy-proven Nonalcoholic Steatohepatitis (NASH)
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Illinois at Chicago

Investigators

  • Principal Investigator: Scott Cotler, M.D., University of Illinois Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (ACTUAL)

October 1, 2010

Study Completion (ACTUAL)

October 1, 2010

Study Registration Dates

First Submitted

February 17, 2009

First Submitted That Met QC Criteria

February 17, 2009

First Posted (ESTIMATE)

February 18, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

July 24, 2013

Last Update Submitted That Met QC Criteria

June 18, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2003-0601

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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