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

Fatty Liver Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00681408
• Other study ID #: 12442
• Secondary ID: R21AT002901IRB #
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: May 19, 2008
• Last updated: May 27, 2015
• Start date: March 2007
• Est. completion date: August 2010

Study information

• Verified date: May 2015
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Federal Government
• Study type: Interventional

Clinical Trial Summary

Nonalcoholic steatohepatitis (NASH) occurs in 2-3% of the US population and carries a 15-20% chance of progression to cirrhosis. It is closely associated with obesity, hyperlipidemia and insulin resistance. Therapy usually includes recommendations to increase exercise and to begin weight reducing diets but these goals are variably achieved and their relative effects in conjunction with pharmacological intervention have not been well defined. Moreover, these lifestyle changes can confound results of treatment trials if not quantified through conditioning testing and measures of body fat. Polyunsaturated fatty acids, especially formulation rich in omega-3, are widely accepted and endorsed in the medical community for their beneficial effects on hyperlipidemia and coronary disease risk reduction. Recent data suggests that omega-3 fatty acids ameliorate hepatic steatosis in humans and in animal models of NASH by reducing hepatic fat content. We hypothesize that a one year course of omega-3 fatty acid (3gm/day) will produce improvement in NASH histological injury independent of changes in weight (BMI) or degree of conditioning measured by the lactate threshold. The effects of the supplement will be compared to a placebo group and controlled for these lifestyle changes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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, corticosteroids.

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.

Study Design

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

Related Conditions & MeSH terms

• Fatty Liver
• Non-alcoholic Steatohepatitis

Intervention

Drug:
• Omega 3 Fish Oil supplements
Subjects in this arm will receive 3 grams daily Omega 3 fish oil supplements
• Placebo
Fish oil placebo pills

Locations

Country	Name	City	State
United States	University of Virginia School of Medicine	Charlottesville	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
University of Virginia	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Primary endpoint will be improvement in a composite score of histological injury as measured by the NASH Activity Score (NAS).		approximately 12 months from enrollment	No
Secondary	Measurement of anthropometric indices (weight, BMI, waist circumference)		12 months	No
Secondary	Index of cardiorespiratory fitness determined by exercise tolerance (measured by lactate threshold on an exercise treadmill)		12 months	No
Secondary	Hepatic fat content measured by magnetic resonance imaging		12 months	No
Secondary	Changes in fasting plasma lipids, red cell fatty acid content, changes in anti-hyperlipidemia requirements, insulin sensitivity, and markers of inflammation including tumor necrosis factor and C-reactive protein		12 mos	No