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Status:

COMPLETED

Alpha Omega Trial: Study of Omega-3 Fatty Acids and Coronary Mortality

Lead Sponsor:

Wageningen University

Collaborating Sponsors:

Netherlands Heart Foundation

National Heart, Lung, and Blood Institute (NHLBI)

Conditions:

Cardiovascular Diseases

Eligibility:

All Genders

60-80 years

Phase:

NA

Brief Summary

The Alpha Omega Trial is a randomized, placebo-controlled, double-blind dietary intervention study in 4837 postmyocardial infarction patients in the Netherlands to examine whether incidence of cardiov...

Detailed Description

Whether dietary omega-3 (or n-3) polyunsaturated fatty acids are causally related to risk of cardiovascular diseases (CVD) is a major, unresolved question in preventive cardiology. Essential n-3 fatty...

Eligibility Criteria

Inclusion

  • Inclusion criteria:
  • Men and women
  • Aged 60 through 80 y
  • Verified clinically diagnosed myocardial infarction up to 10 y before randomization
  • Written informed consent
  • Exclusion criteria:
  • Living in a nursing home or other institution
  • Participation in another scientific study
  • Habitual margarine intake \< 10 g per day
  • Habitual fish intake \> 150 g per day
  • Habitual alcohol intake \> 6 drinks per day
  • Use of fish oil capsules or other supplements containing omega-3 fatty acids
  • Presence of cancer with \< 1 y of life expectancy
  • Cognitive impairment, as indicated by the Mini Mental State Examination (score \<= 21)
  • Unintended weight loss \> 5 kg in the past year
  • Lack of facilities for cooled margarine storage at home
  • Inability or unwillingness to comply with study procedures

Exclusion

    Key Trial Info

    Start Date :

    April 1 2002

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    June 1 2010

    Estimated Enrollment :

    4837 Patients enrolled

    Trial Details

    Trial ID

    NCT00127452

    Start Date

    April 1 2002

    End Date

    June 1 2010

    Last Update

    July 7 2010

    Active Locations (32)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 8 (32 locations)

    1

    Medisch Centrum Alkmaar

    Alkmaar, Netherlands, 1815 JD

    2

    Flevo Ziekenhuis

    Almere Stad, Netherlands, 1315 RA

    3

    Meander Medisch Centrum

    Amersfoort, Netherlands, 3800 BM

    4

    Sint Lucas Andreas Ziekenhuis

    Amsterdam, Netherlands, 1006 AE