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

NCT00127452 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4837

Last updated 2010-07-07

No results posted yet for this study

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

margarine spread

Daily use of margarine spread (approximately 20 grams) during 40 months

Sponsors & Collaborators

  • Netherlands Heart Foundation

    collaborator OTHER

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Unilever R&D

    collaborator INDUSTRY

  • Wageningen University

    lead OTHER

Principal Investigators

  • Daan Kromhout, PhD MPH · Wageningen University, The Netherlands

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-04-30
Primary Completion
2009-11-30
Completion
2010-06-30

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00127452 on ClinicalTrials.gov