Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00410839
Status:
UNKNOWN
Last Update Posted:
2006-12-13
First Post:
2006-12-12
Brief Title:
Studies of the Prevention of Atrial Fibrillation by ALA
Sponsor:
University of Toronto
Organization:
University of Toronto
Study Overview
Official Title:
Prevention of Atrial Fibrillation Recurrence By An Alpha-Linolenic Enriched Diet - A Pilot Study
Status:
UNKNOWN
Status Verified Date:
2004-08
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
An alpha-linolenic acid ALA rich diet in the Lyon Heart Study reduced sudden cardiac deaths possibly by reducing cardiac arrhythmias and ventricular fibrillation Lancet 1994 Since then there has been a growing interest in ALA as a cardioprotective nutrient Much of the interest has focused on the potential antiarrhythmic effect of ω-3 fatty acids especially the longer chain ω-3 fatty acids DHA and EPA derived from fish We therefore concluded it important to test whether the shorter chain ω-3 vegetable oil ALA also had antiarrhythmic effects since this might also explain the beneficial effects seen on cardiovascular mortality in the Lyon Heart Study
Detailed Description:
Objective We determined the effect of an ALA rich diet in reducing recurrence of atrial fibrillation as a further example of a cardiac arrhythmia
Design Randomized parallel design efficacy study Setting Three university hospital centers in the Bordeaux region France Patients 98 successive patients successfully underwent electro cardioversion of whom 75 completed the study without major deviations according to the protocol
Intervention A canola margarine and oil together with a Mediterranean diet ALA ω-3 14 gd versus a conventional diet control with a one year follow-up
Main outcome measure Length of time to first recurrence of atrial fibrillation
Significance If ALA is antiarrhythmic this action may explain its cardioprotective effect in clinical trials and cohort studies
Design Randomized parallel design efficacy study Setting Three university hospital centers in the Bordeaux region France Patients 98 successive patients successfully underwent electro cardioversion of whom 75 completed the study without major deviations according to the protocol
Intervention A canola margarine and oil together with a Mediterranean diet ALA ω-3 14 gd versus a conventional diet control with a one year follow-up
Main outcome measure Length of time to first recurrence of atrial fibrillation
Significance If ALA is antiarrhythmic this action may explain its cardioprotective effect in clinical trials and cohort studies
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