Ignite Creation Date:
2024-05-05 @ 9:22 PM
Last Modification Date:
2024-10-26 @ 10:03 AM
Study NCT ID:
NCT00871377
Status:
COMPLETED
Last Update Posted:
2014-02-07
First Post:
2009-03-27
Brief Title:
Double Blind Crossover Study of Fish Oil EPA and DHA for Intractable Partial Seizures
Sponsor:
National Center for Complementary and Integrative Health NCCIH
Organization:
National Center for Complementary and Integrative Health NCCIH
Study Overview
Official Title:
Pilot Randomized Double Blind Crossover Study Of Fish Oil Eicosapentaenoic Acid EPA And Docosahexaenoic Acid DHA For Intractable Partial Seizures
Status:
COMPLETED
Status Verified Date:
2014-01
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:
FOS
Brief Summary:
The purpose of this study is to determine if Omega-3 fatty acids reduce seizures and modify cardiac risk factors in people with epilepsy
Detailed Description:
Epilepsy is a common and disabling condition characterized by recurrent seizures Sudden unexpected death SUDEP is a major cause of mortality in people with epilepsy SUDEP accounts for up to 20 of all cause mortality and is most common in younger people especially in their 20s to 40s year olds In those with drug resistant epilepsy SUDEP is five times more common than in well-controlled epilepsy Likely causes of death include cardiac arrhythmias due to impaired autonomic regulation and reduced heart rate variability Similarly patients with recent myocardial infarction and congestive heart failure are at higher risk for sudden death and manifest markedly reduced heart rate variability Clinical studies of heart disease indicate that n-3 fatty acids prevent cardiac arrhythmias reduce mortality after myocardial infarction and reduce the risk of sudden cardiac death The mechanism by which EPA and DHA exert their anti-arrhythmia effect is due to inactivation of high frequency sodium and L-type calcium channels in the heart In addition n-3 fatty acids improve HRV in cardiac patients and this reduction in HRV is postulated to be a marker of the anti-arrhythmic effect of n-3 fatty acids Preliminary data from our group indicates that n-3 fatty acids improve HRV in people with epilepsy especially those with low HRV SDNN 50 The commonality between n-3 fatty acids and improvement in HRV in patients with heart disease and epilepsy serves as a basis for our hypothesis that n-3 fatty acids may reduce the risk of SUDEP in epilepsy The purpose of this proposal is to determine if n-3 fatty acids reduce seizures and modify cardiac risk in people with epilepsy who are at risk of SUDEP
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