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

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ClinicalTrials.gov Identifier: NCT00681408
Recruitment Status : Completed
First Posted : May 21, 2008
Last Update Posted : May 29, 2015
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Stephen Caldwell, MD, University of Virginia

Tracking Information
First Submitted Date  ICMJE May 19, 2008
First Posted Date  ICMJE May 21, 2008
Last Update Posted Date May 29, 2015
Study Start Date  ICMJE March 2007
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 20, 2008)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00681408 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 20, 2008)
  • Measurement of anthropometric indices (weight, BMI, waist circumference) [ Time Frame: 12 months ]
  • Index of cardiorespiratory fitness determined by exercise tolerance (measured by lactate threshold on an exercise treadmill) [ Time Frame: 12 months ]
  • Hepatic fat content measured by magnetic resonance imaging [ Time Frame: 12 months ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Omega 3 Fish Oil Supplements vs. Placebo for Patients With Non-alcoholic Steatohepatitis (NASH)
Official Title  ICMJE Omega 3 Fish Oil Supplements vs. Placebo for Patients With Non-alcoholic Steatohepatitis (NASH)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Non-alcoholic Steatohepatitis
  • Fatty Liver
Intervention  ICMJE
  • Drug: Omega 3 Fish Oil supplements
    Subjects in this arm will receive 3 grams daily Omega 3 fish oil supplements
    Other Name: Fish Oil capsules
  • Drug: Placebo
    Fish oil placebo pills
Study Arms  ICMJE
  • Active Comparator: Omega 3 recipient arm
    Intervention: Drug: Omega 3 Fish Oil supplements
  • Placebo Comparator: Placebo
    Placebo fish oil
    Intervention: Drug: Placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 27, 2015)
41
Original Estimated Enrollment  ICMJE
 (submitted: May 20, 2008)
64
Actual Study Completion Date  ICMJE August 2010
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00681408
Other Study ID Numbers  ICMJE 12442
R21AT002901 ( U.S. NIH Grant/Contract )
IRB # 12442
GCRC: SHC003
Grant # 5R21AT2901-2
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Stephen Caldwell, MD, University of Virginia
Study Sponsor  ICMJE University of Virginia
Collaborators  ICMJE National Center for Complementary and Integrative Health (NCCIH)
Investigators  ICMJE
Principal Investigator: Stephen H Caldwell, MD University of Virginia
PRS Account University of Virginia
Verification Date May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP