Efficacy of Vitamin K2 Supplementation in Adult Episodic Migraine
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Changes of monthly migraine days
研究概览
简要总结
Migraine is a debilitating illness and a major cause of disability in the world. It is highly prevalent, especially among women. Vitamin supplementation is a potential therapeutic option for migraines that remains largely under-explored. Several studies have shown that people with migraine tend to have higher arterial stiffness than people without migraine. Vitamin K2 deficiency is an important mediator of arterial stiffness and calcification due to decreased carboxylation of matrix Gla protein (MGP). Supplementation reverses these changes and improves vascular health in patients with end stage renal disease according to previous studies. Therefore, vitamin K2 supplementation could serve a potential role in migraine patients. The purpose of the study is to test the effect of vitamin K2 on decreasing the frequency of migraine attacks and decreasing arterial stiffness. The population will be recruited from the neurology clinic at LAU Medical Center-Rizk Hospital and will constitute of adult patients. They will be randomized to receive either the supplement of vitamin K2 or a placebo for the duration of 6 months. Laboratory tests and arterial stiffness measurements will be done at the beginning, middle, and at the end of the study for comparison.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Patients, investigators, and analysts will remain blind to the identity of the treatment from the time of randomization until the time of unblinding. The identity of the treatment will be concealed by using placebo pills that are identical in appearance, color, odor and packaging. Unblinding will only occur in the case of a medical emergency and at the conclusion of the study.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years or above
- •History of episodic migraine with or without aura since > 12 months according to the ICHD-3 criteria.
- •Migraine frequency from 4-14 days per month over the 3 months prior to screening.
- •Migraine frequency from 4-14 days per month during the baseline period of assessment.
- •Successful completion of the migraine diary during the baseline evaluation period.
排除标准
- •Migraine patients with superimposed tension type or other forms of primary headaches
- •Patients who are currently on any of the migraine prophylactic treatments (Sodium valproate, Topiramate, Beta-blockers, Tricyclic antidepressants, SRNI, Flunarizine, Verapamil, Lisinopril, Candesartan)
- •Patients who have been on any of the previously listed medications within 3 months of screening
- •Patient who takes the following medications:
- •Ergotamine or Triptans > 10 days per month
- •NSAIDs or paracetamol > 15 days per month
- •Opioids more than 4 days per month
- •Patients on anticoagulants
- •Other active chronic pain syndromes (i.e. fibromyalgia, painful peripheral neuropathy, post-herpetic neuralgia…)
- •History of hypersensitivity to the vitamin K2
- •History of soy protein, cheese, eggs and meat allergy
- •History of thrombotic events
- •Diagnosed coagulopathy or any condition related to coagulation
- •Cardiovascular event in the past month
- •Current or planned pregnancy
- •Lactation
- •Inability to tolerate oral medications
- •Known intestinal malabsorption or hypomotility syndromes
- •Atrial fibrillation
- •Active malignancy
- •Any acute illness in the past month
结局指标
主要结局
Changes of monthly migraine days
时间窗: 6 months
Effect of Vitamin K2 supplementation on the changes from baseline in monthly migraine days as compared to placebo. This will be assessed clinically using a questionnaire to be administered at the start, monthly, and at the end of the study (6 months) about frequency and number of migraine days per month.
次要结局
- Changes from baseline in the headache impact score (HIT-6) as compared to placebo.(6 months)
- Changes from baseline in monthly severe migraine days.(6 months)
- Changes from baseline on the modified migraine disability assessment (MIDAS) score as compared to placebo.(6 months)
- Changes from baseline on the modified migraine physical function impact diary (MPFID) as compared to placebo.(6 months)
- Changes from baseline on the quality of life as measure by the EuroQoL compared to placebo.(6 months)
- Changes from baseline of arterial stiffness level.(6 months)
研究者
Sola Aoun Bahous, M.D. Ph.D.
Professor of Medicine
Lebanese American University