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Completed

NCT Number: NCT00681408

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

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.

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Key information

Conditions

Non-alcoholic Steatohepatitis Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Fatty Liver Disease

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University of Virginia School of Medicine

Charlottesville, Virginia, 22908, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • NASH with NAS (NASH Activity Score) of >4 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.

Treatment and study plan

Omega 3 Fish Oil supplements

Drug

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

Other names: Fish Oil capsules

Placebo

Drug

Fish oil placebo pills

Primary outcomes

  1. 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

Secondary outcomes

  1. Measurement of anthropometric indices (weight, BMI, waist circumference)

    Time frame: 12 months

  2. Index of cardiorespiratory fitness determined by exercise tolerance (measured by lactate threshold on an exercise treadmill)

    Time frame: 12 months

  3. Hepatic fat content measured by magnetic resonance imaging

    Time frame: 12 months

  4. 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

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
May 21, 2008
Registry last updated
May 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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