PILOT, RANDOMIZED, DOUBLE-BLIND, CROSSOVER STUDY OF FISH OIL [EPA AND DHA] FO

鱼油 [EPA 和 DHA] FO 试点、随机、双盲、交叉研究

• 批准号: 7606827
• 负责人: CHRISTOPHER M DEGIORGIO
• 金额: $ 0.34万
• 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: 2007-02-21 至 2007-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7606827
• 关键词: Address; Adult; Arrhythmia; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Cross-Over Studies; Data; Docosahexaenoic Acids; Double-Blind Method; Effectiveness; Epilepsy; Fatty Acids; Fish Oils; Frequencies; Funding; Goals; Grant; Institution; Intractable Epilepsy; Patients; Placebos; Randomized; Research; Research Personnel; Resources; Risk; Safety; Seizures; Severities; Source; Supplementation; United States Environmental Protection Agency; United States National Institutes of Health; response

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. SPECIFIC AIMS: The primary goal of this study is to determine if Fish Oil reduces seizures and the risk of cardiac arrhythmias in people with epilepsy. This fundamental hypothesis will be addressed in a pilot clinical trial, which explores the following two specific aims: Specific Aim 1: To obtain preliminary data regarding the safety and effectiveness of Fish Oil compared with placebo in reducing seizure frequency in adults with intractable epilepsy. Hypothesis 1a. Fish Oil is safe and well tolerated in subjects with epilepsy. Hypothesis 1b. Seizure frequency and severity is reduced during active treatment with Fish Oil compared with placebo. Hypothesis 1c. Levels of the N-3 fatty acids, EPA and DHA, rise significantly in epileptic patients after supplementation, and are correlated with response.

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 具体目标： 这项研究的主要目的是确定鱼油是否能减少癫痫患者的癫痫发作和心律失常的风险。这一基本假设将在一项初步临床试验中得到解决，该试验探讨了以下两个具体目标： 具体目标1：获得鱼油与安慰剂相比在降低成人难治性癫痫发作频率方面的安全性和有效性的初步数据。 假设1A。鱼油在癫痫患者中安全且耐受性良好。 假设1b。与安慰剂相比，鱼油活性治疗期间癫痫发作频率和严重程度降低。 假设1C。N-3脂肪酸，EPA和DHA的水平在癫痫患者补充后显着上升，并与反应相关。