Omega 3 Fish Oil for Nonalcoholic Steatohepatitis - Full Text View

Sponsored by:	National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by:	National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:	NCT00681408

Purpose

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.

Condition	Intervention	Phase
Non-Alcoholic Steatohepatitis Fatty Liver	Drug: Omega 3 Fish Oil supplements Drug: Placebo	Phase II Phase III

MedlinePlus related topics: Dietary Supplements Exercise and Physical Fitness

Drug Information available for: Fish oil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Omega 3 Fish Oil Supplements vs. Placebo for Patients With Non-Alcoholic Steatohepatitis (NASH)

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Primary Outcome Measures:

The Primary endpoint will be improvement in a composite score of histological injury as measured by the NASH Activity Score (NAS). [ Time Frame: approximately 12 months from enrollment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Measurement of anthropometric indices (weight, BMI, waist circumference) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Index of cardiorespiratory fitness determined by exercise tolerance (measured by lactate threshold on an exercise treadmill) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Hepatic fat content measured by magnetic resonance imaging [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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 [ Time Frame: 12 mos ] [ Designated as safety issue: No ]

Estimated Enrollment:	64
Study Start Date:	March 2007
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Omega 3 recipient arm: Active Comparator	Drug: Omega 3 Fish Oil supplements Subjects in this arm will receive 3 grams daily Omega 3 fish oil supplements
Placebo: Placebo Comparator Placebo fish oil	Drug: Placebo Fish oil placebo pills

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

NASH with NAS (NASH Activity Score) of >5 evident on a biopsy performed within 6 months of enrollment.
Age 21 years or older.
BMI 25 or greater.
Ability to provide informed consent.

Exclusion Criteria:

Cirrhosis evident clinically or on biopsy.
Secondary forms of NASH such as that seen with bariatric surgery or medication induced from such medications as methotrexate, amiodarone, tamoxifen, corticosteroids.
Current or past history of diabetes or hyperlipidemia requiring specific drug therapy (see below).
Current use of a weight loss medicine, such as a 'fat-burner' or similar agent
Alcohol consumption > 30 g/day, currently or for more than 3 consecutive months within 5 years.
Other liver disease (hepatitis C,B, Wilson's, autoimmune, ct-1-antitrypsin and hemochromatosis or HIV
Pregnancy or unwillingness to use an effective form of birth control for women of child bearing years.
Renal insufficiency (creatinine > 2), symptomatic coronary, peripheral or neurovascular disease, symptomatic heart failure or advanced respiratory disease requiring oxygen therapy.
Inability to provide informed consent.
Any condition in the opinion of the primary investigator that would contraindicate the patient's participation.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00681408

Locations

United States, Virginia
University of Virginia School of Medicine	Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Stephen H Caldwell, MD 434-924-2626 shc5c@virginia.edu
Principal Investigator: Stephen H Caldwell, MD

Sponsors and Collaborators

National Center for Complementary and Alternative Medicine (NCCAM)

Investigators

Principal Investigator:

Stephen H Caldwell, MD

University of Virginia

More Information

Responsible Party:	University of Virginia Health System, Division of Gastroenterology ( Stephen H. Caldwell, MD )
Study ID Numbers:	R21 AT002901, IRB # 12442, GCRC: SHC003, Grant # 5R21AT2901-2
Study First Received:	May 19, 2008
Last Updated:	May 20, 2008
ClinicalTrials.gov Identifier:	NCT00681408
Health Authority:	United States: Food and Drug Administration; United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):

Steatohepatitis
NASH
NAFLD
omega 3 fatty acids
Exercise conditioning

Study placed in the following topic categories:

Liver Diseases
Non-alcoholic steatohepatitis (NASH)
Digestive System Diseases
Fatty Liver

ClinicalTrials.gov processed this record on January 14, 2009