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

NCT ID: NCT00681408

Last Updated: 2015-05-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2010-08-31

Brief 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.

Conditions

Non-alcoholic Steatohepatitis; Fatty Liver

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Omega 3 recipient arm

Group Type: ACTIVE_COMPARATOR

Omega 3 Fish Oil supplements

Intervention Type: DRUG

Subjects in this arm will receive 3 grams daily Omega 3 fish oil supplements

Placebo

Placebo fish oil

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Fish oil placebo pills

Interventions

Omega 3 Fish Oil supplements

Subjects in this arm will receive 3 grams daily Omega 3 fish oil supplements

Intervention Type: DRUG

Placebo

Fish oil placebo pills

Intervention Type: DRUG

Other Intervention Names

Fish Oil capsules

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

University of Virginia

OTHER

Sponsor Role: lead

Responsible Party

Stephen Caldwell, MD

Professor, Department of Gastroenterology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephen H Caldwell, MD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

University of Virginia School of Medicine

Charlottesville, Virginia, United States

Countries

United States

References

Argo CK, Patrie JT, Lackner C, Henry TD, de Lange EE, Weltman AL, Shah NL, Al-Osaimi AM, Pramoonjago P, Jayakumar S, Binder LP, Simmons-Egolf WD, Burks SG, Bao Y, Taylor AG, Rodriguez J, Caldwell SH. Effects of n-3 fish oil on metabolic and histological parameters in NASH: a double-blind, randomized, placebo-controlled trial. J Hepatol. 2015 Jan;62(1):190-7. doi: 10.1016/j.jhep.2014.08.036. Epub 2014 Sep 6.

Reference Type: DERIVED

PMID: 25195547 (View on PubMed)

Other Identifiers

R21AT002901

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB # 12442

Identifier Type: -

Identifier Source: secondary_id

GCRC: SHC003

Identifier Type: -

Identifier Source: secondary_id

Grant # 5R21AT2901-2

Identifier Type: -

Identifier Source: secondary_id

12442

Identifier Type: -

Identifier Source: org_study_id