Pilot Randomized, Double-Blind Crossover Study of Fish Oil [EPA and DHA] For Intr

鱼油 [EPA 和 DHA] 的试点随机、双盲交叉研究

• 批准号: 7484912
• 负责人: CHRISTOPHER M DEGIORGIO
• 金额: $ 18.87万
• 依托单位: UNIVERSITY OF CALIFORNIA LOS ANGELES
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-09-01 至 2010-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7484912
• 关键词: Adult; Age; Animal Model; Antiepileptic Agents; Arrhythmia; Brain; Cause of Death; Child; Clinical Trials; Cognition; Complex; Condition; Congenital Abnormality; Cross-Over Studies; Data; Docosahexaenoic Acids; Double-Blind Method; Effectiveness; Enrollment; Epilepsy; Fish Oils; Folic Acid; Foundations; Frequencies; Future; Goals; Heart; Heart Diseases; Heart Rate; Injury; Intervention; L-Type Calcium Channels; Measures; Memory; Mothers; Omega-3 Fatty Acids; Patients; Pharmacotherapy; Phase II Clinical Trials; Placebos; Play; Population; Prevention; Process; Public Health; Purpose; Randomized; Rate; Refractory; Regulation; Resistance; Rest; Risk; Role; Safety; Seizures; Severities; Sodium; Sudden Death; Supplementation; Thinking; Tonic - clonic seizures; United States Environmental Protection Agency; Ventricular Premature Complexes; Week; animal data; cognitive function; concept; design; disability; human data; improved; indexing; prevent

DESCRIPTION (provided by applicant): Epilepsy is a major cause of disability worldwide. Many people with epilepsy are treatment resistant, and are also at risk for a condition called sudden death. Interventions that reduce both seizures and sudden death have yet to be developed. Human data indicate that omega-3 fatty acids, (EPA and DHA, the principal ingredients of fish oil), reduce cardiac arrhythmias and sudden death in those with heart disease. EPA and DHA also reduce seizures in accepted animal models of epilepsy. If omega-3 fatty acid (fish oil) supplementation reduces seizures and the risk for sudden death, it would represent a major advance in the treatment of epilepsy. The central goals of this study are to determine if fish oil reduces seizures, and reduces the risk of cardiac arrhythmias and sudden death in people with epilepsy. A secondary goal is to determine if fish oil improves cognition in this population. We propose a pilot clinical trial, which explores the following Specific Aims: First, to obtain preliminary data regarding the safety and effectiveness of fish oil compared with placebo in reducing seizure frequency and seizure severity. Second, we will evaluate the effect of fish oil on variables related to the risk of sudden death, especially heart rate variability. This study is designed to be a proof of concept study of fish oil in epilepsy. Thirty children and adults, ages 16 - 70, with three or more simple partial, complex partial, or secondarily generalized tonic-clonic seizures per month will be enrolled in a 36-week study. If successful, this study will lay a foundation for future studies of fish oil for epilepsy. Public Health Relevance: Epilepsy is a major cause of injury and disability throughout the world. Many people with epilepsy are poorly controlled, and are at risk for a condition called sudden death in epilepsy. The purpose of this study is to investigate whether omega-3 fatty acids (as fish oil) benefit people with epilepsy by reducing seizures, preventing sudden death, and improving memory and thinking processes.

描述（由申请人提供）：癫痫是全球残疾的主要原因。许多癫痫患者对治疗有抵抗力，并且也有可能患上一种叫做猝死的疾病。减少癫痫发作和猝死的干预措施尚未开发。人体数据表明，ω-3脂肪酸（EPA和DHA，鱼油的主要成分）可以减少心脏病患者的心律失常和猝死。EPA和DHA还可以减少癫痫动物模型的发作。如果补充omega-3脂肪酸（鱼油）可以减少癫痫发作和猝死的风险，这将代表癫痫治疗的重大进展。 这项研究的中心目标是确定鱼油是否能减少癫痫发作，降低癫痫患者心律失常和猝死的风险。第二个目标是确定鱼油是否能改善这一人群的认知能力。 我们提出了一个试点临床试验，探讨了以下具体目标：首先，获得初步数据的安全性和有效性的鱼油相比，安慰剂在减少癫痫发作的频率和癫痫发作的严重程度。其次，我们将评估鱼油对猝死风险相关变量的影响，特别是心率变异性。本研究旨在证明鱼油治疗癫痫的概念研究。30名儿童和成人，年龄16 - 70岁，每月有3次或3次以上的简单部分性、复杂部分性或继发性全身性强直阵挛性癫痫发作，将入组36周研究。如果成功，本研究将为今后鱼油治疗癫痫的研究奠定基础。 公共卫生相关性：癫痫是世界各地伤害和残疾的主要原因。许多癫痫患者控制不佳，并且有患癫痫猝死的风险。这项研究的目的是调查omega-3脂肪酸（如鱼油）是否通过减少癫痫发作，预防猝死，改善记忆和思维过程而使癫痫患者受益。