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临床试验研究了使用高剂量维生素D3在预防簇头痛中招募患者的临床试验

September 30, 2021
Caitie Barkley

群集头痛以周期性的模式称为簇期,比分娩或肾结石更痛苦,可以持续15分钟到三个小时。(盖蒂图像照片)
群集头痛以周期性的模式称为簇期,比分娩或肾结石更痛苦,可以持续15分钟到三个小时。(盖蒂图像照片)
马克·伯里什(Mark Burish),医学博士,博士,维维安·L·史密斯(Vivian L. Smith)神经外科助理教授,麦戈文医学院(McGovern Medical School)
马克·伯里什(Mark Burish),医学博士,博士,维维安·L·史密斯(Vivian L. Smith)神经外科助理教授,麦戈文医学院(McGovern Medical School)

临床试验调查高剂量是否vitamin D3 supplements combined with a multivitamin could effectively prevent cluster headaches is now recruiting patients at The University of Texas Health Science Center at Houston (UthealthHouston)。

这项研究,由马克·伯里什(Mark Burish),医学博士,博士,维维安·史密斯(Vivian L. Smith)神经外科助理教授与休斯敦Uthealth的麦戈文医学院(McGovern Medical School)的启发,其灵感来自Cluster Busters的反馈,这是一个患者经营的社区支持小组,其成员遭受了群集头痛攻击。

伯里什说:“群集克星小组的成员已经为其他医疗问题服用了高剂量的维生素D补充剂,并说它为他们的集群头痛起作用,所以我变得很感兴趣。”德克萨斯大学医学博士安德森癌症中心Uthealth生物医学研究生院的教师。“这就是发现很多头痛药物的方式;例如,我们认为偏头痛不是肌肉疾病,但是患有偏头痛的人出于整容原因而肉毒杆菌毒素,并发现它对偏头痛有所帮助。我们正在测试患者认为可能会有所帮助。”

簇头痛以循环模式称为群集时期,比分娩或肾结石更痛苦。最近的研究由Burish和其他一些研究人员表演。beplay苹果手机能用吗聚类的头痛通常在半夜唤醒一个人,头部一侧的眼睛内或周围的疼痛令人发指,一次攻击持续15分钟到三个小时。大多数攻击每天同时发生。

最初,参加Burish研究的人经历了筛查过程,其中包括访谈,检查,调查反应和血液工作。

The trial is seven weeks long. The first week of the trial is a baseline period, with no added medications. The second through fourth weeks are a double-blinded experimental period during which participants receive either high-dose vitamin D3 plus a multivitamin, or a placebo plus a multivitamin. During this time, participants fill out a survey and undergo blood testing.

第五周至第七周是一个开放标签时期,在此期间,所有参与者都接受高剂量维生素D3和多种维生素。

At the end of the seven-week period for each patient, Burish will measure changes in the average weekly frequency of cluster headache attacks among participants who received the high-dose vitamin D3 versus the placebo, along with other outcomes.

“Cluster headache is such an understudied disease, but it’s an extremely painful disorder,” Burish said, noting a previous study showing that more than 50% of individuals suffering from the attacks have had suicidal thoughts. “But based on previous research, vitamin D seems to block CGRP, a pain-signaling molecule that is commonly found in migraines and cluster headache, so we see a lot of promise with it.”

Overall, Burish is looking for roughly 220 study participants. To be eligible for enrollment, participants must be between 18 and 70 years old and have a diagnosis of either episodic or chronic cluster headache. They must also have predictable cluster periods that last at least six weeks, with a minimum of one attack daily.

参与者可能会在美国的任何地方都可以参加参加血液工作的实验室。有关研究的更多信息,请访问临床试验发布或致电713-486-7771致电RN Rebecca Martinez。

The study, expected to last through mid-2024, is being funded by the Erwin family.

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