Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00127452
Status:
COMPLETED
Last Update Posted:
2010-07-07
First Post:
2005-08-03
Brief Title:
Alpha Omega Trial Study of Omega-3 Fatty Acids and Coronary Mortality
Sponsor:
Wageningen University
Organization:
Wageningen University
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2010-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 mgday of eicosapentaenoic acid and docosahexaenoic acid on incidence of cardiovascular diseases and
to examine the effect of low-dose supplementation 2 gday of alpha-linolenic acid on incidence of cardiovascular diseases
to examine the effect of low-dose supplementation 400 mgday of eicosapentaenoic acid and docosahexaenoic acid on incidence of cardiovascular diseases and
to examine the effect of low-dose supplementation 2 gday 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 C205 n-3 and docosahexaenoic acid DHA C226 n-3 on one hand and their parent compound alpha-linolenic acid ALA C183 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 gd of ALA 400 mgd of EPA-DHA 2 gd ALA 400 mgd 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 ie 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5R01HL076200 | NIH | None | httpsreporternihgovquickSearch5R01HL076200 |
| NHF-2000T401 | None | None | None |
| L01049 | None | None | None |