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临床试验/NCT00871377
NCT00871377已完成2 期

Pilot Randomized Double Blind Crossover Study Of Fish Oil [Eicosapentaenoic Acid (EPA) And Docosahexaenoic Acid (DHA)] For Intractable Partial Seizures

National Center for Complementary and Integrative Health (NCCIH)1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2008年5月最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
24
试验地点
1
主要终点
Seizure Frequency

研究概览

简要总结

The purpose of this study is to determine if Omega-3 fatty acids reduce seizures and modify cardiac risk factors in people with epilepsy.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Placebo

Placebo Comparator

Corn Oil Placebo (n-6 fatty acids)

干预措施: Placebo (Drug)

High Dose Fish Oil

Experimental

2160 mg of EPA + DHA

干预措施: High Dose Fish Oil (Drug)

Low Dose Fish Oil

Experimental

1060 mg of EPA + DHA

干预措施: Low Dose Fish Oil (Drug)

结局指标

主要结局

Seizure Frequency

时间窗: Study completion (42 weeks)

Seizure frequency (seizures per day or seizures per month)

次要结局

未报告次要终点

研究者

申办方类型
Nih
责任方
Principal Investigator
主要研究者

DeGiorgio, Chris

Assistant Professor

National Center for Complementary and Integrative Health (NCCIH)

研究点 (1)

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