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

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ClinicalTrials.gov Identifier: NCT00127452
Recruitment Status : Completed
First Posted : August 5, 2005
Last Update Posted : July 7, 2010
Sponsor:
Collaborators:
Netherlands Heart Foundation
National Heart, Lung, and Blood Institute (NHLBI)
Unilever R&D
Information provided by:
Wageningen University

Tracking Information
First Submitted Date  ICMJE August 3, 2005
First Posted Date  ICMJE August 5, 2005
Last Update Posted Date July 7, 2010
Study Start Date  ICMJE April 2002
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 21, 2009)
Major cardiovascular events, which comprises fatal cardiovascular diseases (CVD), non-fatal myocardial infarction, non-fatal cardiac arrest, non-fatal stroke and cardiac interventions (PCI and CABG) [ Time Frame: monitored during intervention ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 3, 2005)
Coronary mortality during 3 years of follow-up
Change History Complete list of historical versions of study NCT00127452 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 15, 2010)
  • Incident CVD, which comprises fatal CVD, non-fatal myocardial infarction, non-fatal cardiac arrest and non-fatal stroke [ Time Frame: monitored during intervention ]
  • Fatal CVD, which comprises mortality from ischaemic heart disease, fatal cardiac arrest, sudden death undefined, mortality from heart failure and fatal stroke [ Time Frame: monitored during intervention ]
  • Fatal CHD, which comprises mortality from ischaemic heart disease, mortality from cardiac arrest, and sudden death undefined [ Time Frame: monitored during intervention ]
  • All-causes mortality [ Time Frame: monitored during intervention ]
  • The composite of sudden death undefined and nonfatal and fatal cardiac arrest [ Time Frame: monitored during intervention ]
  • The composite of sudden death undefined, nonfatal and fatal cardiac arrest, and self-reported placement of any implantable cardioverter-defibrillator, verified in medical records [ Time Frame: monitored during intervention ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 3, 2005)
  • Cardiovascular mortality during 3 years of follow-up
  • All cause mortality during 3 years of follow-up
  • Sudden cardiac death during 3 years of follow-up
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Alpha Omega Trial: Study of Omega-3 Fatty Acids and Coronary Mortality
Official Title  ICMJE Alpha Omega Trial: A Randomised, Placebo Controlled, Double Blind Intervention Study of the Effect of Low Doses of Omega-3 Fatty Acids on Cardiovascular Diseases in Patients With a History of Myocardial Infarction
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 cardiovascular diseases during 40 months of follow-up can be prevented by low doses of omega-3 polyunsaturated fatty acids. The key objectives are:

  • to examine the effect of low-dose supplementation (400 mg/day) of eicosapentaenoic acid and docosahexaenoic acid on incidence of cardiovascular diseases; and
  • to examine the effect of low-dose supplementation (2 g/day) of alpha-linolenic acid on incidence of cardiovascular diseases.
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 acids are eicosapentaenoic acid (EPA; C20:5, n-3) and docosahexaenoic acid (DHA; C22:6, n-3) on one hand, and their parent compound alpha-linolenic acid (ALA; C18:3, n-3) on the other hand. The intake of n-3 fatty acids is below recommended levels in most Western populations. The Alpha Omega Trial is a randomized, double-blind, placebo-controlled study of the effect of low-dose supplementation of ALA and EPA-DHA on CVD. A total of 4837 Dutch men and women aged 60-80 years who had a myocardial infarction in the past 10 years are randomly allocated to 2 g/d of ALA, 400 mg/d of EPA-DHA, 2 g/d ALA + 400 mg/d EPA-DHA, or placebo, for 40 months. Increased intake of n-3 fatty acids is achieved through daily use of 20 g of margarine on bread. Margarines for all treatment groups are similar in taste and appearance. The primary outcome of the trial is 'major cardiovascular events', which comprises incident CVD and cardiac interventions (PCI and CABG) during follow-up. Secondary endpoints are incident CVD, fatal CVD, fatal CHD and all-causes mortality. Complete follow-up for vital status is achieved. Cause-specific mortality is coded by an independent Endpoint Adjudication Committee. Physical examination, blood sampling and data collection on diet and lifestyle are performed in all subjects at baseline, in 810 randomly selected subjects after 20 months of intervention, and in 58% of the cohort at the end of follow-up. Cardiovascular health, serious adverse events, lifestyle, fish intake and margarine use are monitored in all subjects by yearly telephone interviews. Compliance is continuously monitored by registration of margarine tubs. An objective biomarker of compliance (i.e. plasma n-3 fatty acids) is obtained in randomly selected subjects at baseline and after 20 and 40 months of intervention. The Alpha Omega Trial could provide a sound scientific basis for dietary recommendations on intake of ALA and EPA-DHA, in order to reduce the burden of cardiovascular diseases.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Cardiovascular Diseases
Intervention  ICMJE Dietary Supplement: margarine spread
Daily use of margarine spread (approximately 20 grams) during 40 months
Study Arms  ICMJE
  • Experimental: EPA + DHA
    Margarine spread that yields 400 mg of eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA) per day for average margarine use of 20 grams per day
    Intervention: Dietary Supplement: margarine spread
  • Experimental: ALA
    Margarine spread that yields 2 grams of alpha-linolenic acid (ALA) per day for average margarine use of 20 grams per day
    Intervention: Dietary Supplement: margarine spread
  • Experimental: EPA + DHA plus ALA
    Margarine spread that yields 400 mg of EPA + DHA per day plus 2 grams of ALA per day, for average margarine use of 20 grams per day
    Intervention: Dietary Supplement: margarine spread
  • Placebo Comparator: Placebo
    Margarine spread that contains no EPA, DHA or ALA (exchanged for oleic acid)
    Intervention: Dietary Supplement: margarine spread
Publications *

*   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: December 21, 2009)
4837
Original Enrollment  ICMJE
 (submitted: August 3, 2005)
4000
Actual Study Completion Date  ICMJE June 2010
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years to 80 Years   (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 Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00127452
Other Study ID Numbers  ICMJE METC-ZWH 0552
NHF-2000T401
L01.049
5R01HL076200 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Daan Kromhout, Wageningen University
Study Sponsor  ICMJE Wageningen University
Collaborators  ICMJE
  • Netherlands Heart Foundation
  • National Heart, Lung, and Blood Institute (NHLBI)
  • Unilever R&D
Investigators  ICMJE
Principal Investigator: Daan Kromhout, PhD MPH Wageningen University, The Netherlands
PRS Account Wageningen University
Verification Date July 2010

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