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Omega 3 Fish Oil Supplements vs. Placebo for Patients With Non-alcoholic Steatohepatitis (NASH)

Phase 2/Phase 3
21 Years
Not Enrolling
Non-alcoholic Steatohepatitis, Fatty Liver

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Trial Information

Omega 3 Fish Oil Supplements vs. Placebo for Patients With Non-alcoholic Steatohepatitis (NASH)

Inclusion Criteria:

1. NASH with NAS (NASH Activity Score) of >4 evident on a biopsy performed within 6
months of enrollment.

2. Age 21 years or older.

3. BMI 25 or greater.

4. Ability to provide informed consent.

Exclusion Criteria:

1. Cirrhosis evident clinically or on biopsy.

2. Secondary forms of NASH such as that seen with bariatric surgery or medication
induced from such medications as methotrexate, amiodarone, tamoxifen,

3. Current or past history of diabetes or hyperlipidemia requiring specific drug therapy
(see below).

4. Current use of a weight loss medicine, such as a 'fat-burner' or similar agent

5. Alcohol consumption > 30 g/day, currently or for more than 3 consecutive months
within 5 years.

6. Other liver disease (hepatitis C,B, Wilson's, autoimmune, ct-1-antitrypsin and
hemochromatosis or HIV

7. Pregnancy or unwillingness to use an effective form of birth control for women of
child bearing years.

8. Renal insufficiency (creatinine > 2), symptomatic coronary, peripheral or
neurovascular disease, symptomatic heart failure or advanced respiratory disease
requiring oxygen therapy.

9. Inability to provide informed consent.

10. Any condition in the opinion of the primary investigator that would contraindicate
the patient's participation.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

The Primary endpoint will be improvement in a composite score of histological injury as measured by the NASH Activity Score (NAS).

Outcome Time Frame:

approximately 12 months from enrollment

Safety Issue:


Principal Investigator

Stephen H Caldwell, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Virginia


United States: Food and Drug Administration

Study ID:




Start Date:

March 2007

Completion Date:

August 2010

Related Keywords:

  • Non-alcoholic Steatohepatitis
  • Fatty Liver
  • Steatohepatitis
  • NASH
  • omega 3 fatty acids
  • Exercise conditioning
  • Fatty Liver



University of Virginia School of MedicineCharlottesville, Virginia  22908