Double Blind, Crossover Study of Fish Oil [EPA and DHA] for Intractable Partial Seizures (FOS)
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ClinicalTrials.gov Identifier: NCT00871377 |
Recruitment Status
:
Completed
First Posted
: March 30, 2009
Results First Posted
: January 10, 2014
Last Update Posted
: February 7, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Epilepsy | Drug: Placebo Drug: High Dose Fish Oil Drug: Low Dose Fish Oil | Phase 2 |
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 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo
Corn Oil Placebo (n-6 fatty acids)
|
Drug: Placebo
corn oil (n-6 fatty acids)
Other Name: Corn Oil
|
Experimental: High Dose Fish Oil
2160 mg of EPA + DHA
|
Drug: High Dose Fish Oil
n-3 fatty acids, 1060 mg EPA + DHA
|
Experimental: Low Dose Fish Oil
1060 mg of EPA + DHA
|
Drug: Low Dose Fish Oil
n-3 fatty acids, 2160 mg EPA + DHA
|
- 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, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
United States, California | |
UCLA General Clinical Research Center | |
Los Angeles, California, United States, 90095 |
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 Alternative Medicine (NCCAM) |
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 Alternative Medicine (NCCAM):
epilepsy cardiac risk factors memory cognition n-3 fatty acids |
fish oil EPA DHA seizures |
Additional relevant MeSH terms:
Epilepsy Seizures Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Neurologic Manifestations Signs and Symptoms |