Double Blind, Crossover Study of Fish Oil [EPA and DHA] for Intractable Partial Seizures (FOS)
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| ClinicalTrials.gov Identifier: NCT00871377 |
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Recruitment Status :
Completed
First Posted : March 30, 2009
Results First Posted : January 10, 2014
Last Update Posted : February 7, 2014
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Sponsor:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
DeGiorgio, Chris, National Center for Complementary and Integrative Health (NCCIH)
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Epilepsy | Drug: Placebo Drug: High Dose Fish Oil Drug: Low Dose Fish Oil | Phase 2 |
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 20's to 40's 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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 24 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Prevention |
| Official Title: | Pilot Randomized Double Blind Crossover Study Of Fish Oil [Eicosapentaenoic Acid (EPA) And Docosahexaenoic Acid (DHA)] For Intractable Partial Seizures |
| Study Start Date : | May 2008 |
| Actual Primary Completion Date : | May 2011 |
| Actual Study Completion Date : | August 2011 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Pyridoxal 5'-phosphate-dependent epilepsy
| Arm | Intervention/treatment |
|---|---|
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Placebo Comparator: Placebo
Corn Oil Placebo (n-6 fatty acids)
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Drug: Placebo
corn oil (n-6 fatty acids)
Other Name: Corn Oil |
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Experimental: High Dose Fish Oil
2160 mg of EPA + DHA
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Drug: High Dose Fish Oil
n-3 fatty acids, 1060 mg EPA + DHA |
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Experimental: Low Dose Fish Oil
1060 mg of EPA + DHA
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Drug: Low Dose Fish Oil
n-3 fatty acids, 2160 mg EPA + DHA |
Primary Outcome Measures :
- Seizure Frequency [ Time Frame: Study completion (42 weeks) ]Seizure frequency (seizures per day or seizures per month)
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| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male or female, age 18 - 70
- History of intractable localization related/partial onset seizures and generalized tonic/clonic or tonic seizures defined according to International League Against Epilepsy (ILAE) classification as:
- A history compatible with localization related partial epilepsy
- A history of generalized tonic clonic or tonic seizures with loss of consciousness
- Three or more simple partial, complex partial or tonic-clonic seizures per month
- An EEG and/or an MRI consistent with a localization related epilepsy
- Evidence of at least three seizures per month for at least two months prior to the study
- Exposure to at least one antiepileptic drug at adequate dose
Exclusion Criteria:
- Significant or progressive medical, cardiac, or other illness
- Allergy to fish products or fish oil
- History of a coagulation disorder
- History of non-epileptic seizures
- Consumption of Fish Oil at any time 30 days or less prior to enrollment
- Any change in antiepileptic drugs for 30 days or less prior to enrollment
- Treatment with Warfarin for 30 days or less prior to enrollment
- Previous poor compliance with therapy
- Drug or alcohol abuse
- Uncountable seizures as a result of seizure clustering, or inadequate supervision if the patient cannot count their own seizures.
- Pregnancy
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00871377
Locations
| United States, California | |
| UCLA General Clinical Research Center | |
| Los Angeles, California, United States, 90095 | |
Sponsors and Collaborators
National Center for Complementary and Integrative Health (NCCIH)
Investigators
| Principal Investigator: | Christopher M DeGiorgio, MD | David Geffen - UCLA School of Medicine |
Additional Information:
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | DeGiorgio, Chris, Assistant Professor, National Center for Complementary and Integrative Health (NCCIH) |
| ClinicalTrials.gov Identifier: | NCT00871377 History of Changes |
| Other Study ID Numbers: |
R21AT003420-01A2 ( U.S. NIH Grant/Contract ) |
| First Posted: | March 30, 2009 Key Record Dates |
| Results First Posted: | January 10, 2014 |
| Last Update Posted: | February 7, 2014 |
| Last Verified: | January 2014 |
Keywords provided by DeGiorgio, Chris, National Center for Complementary and Integrative Health (NCCIH):
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epilepsy cardiac risk factors memory cognition n-3 fatty acids |
fish oil EPA DHA seizures |
Additional relevant MeSH terms:
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Epilepsy Seizures Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Neurologic Manifestations Signs and Symptoms |