The Effects of Vitamin D Plus Omega-3 Polyunsaturated Fatty Acids in Patients With Episodic Migraine
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Change of migraine days per month from baseline
研究概览
简要总结
First, the aims of this study are to explore the effect of vitamin D versus placebo in the prevention of episodic migraine. Second, we would like to compare and evaluate the effect of vitamin D plus omega-3 fatty acids versus placebo plus omega-3 fatty acids in terms of migraine frequency, symptom severity, and associated complications.
详细描述
The purpose of this study is to investigate the effects of supplementing with Omega-3 fatty acids and vitamin D on the prevention of muscle atrophy and lifestyle performance in migraine patients. Furthermore, it aims to understand the biological mechanisms of action of Omega-3 fatty acids and vitamin D in decreasing migraine attacks, the severity of headaches, and associated complications, as well as inflammatory markers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 20-65 years
- •Episodic migraine diagnosis with ICHD-3
- •Baseline migraine days between 4 and 15 days per month
- •Episodic migraine without or without aura
- •Blood Vit D< 30ng/mL at baseline
- •With completed informed consent
排除标准
- •Non-migraine (ex: tension-type headache or secondary headache)
- •Having major head trauma in the past
- •Alcoholism within 1 year
- •Patients with abnormal liver and kidney function and patients with other serious diseases such as infection with any inflammation
- •Pregnant women or women who are still breastfeeding
- •Those who are unable to cooperate with the progress of the trial and who have participated in other clinical studies.
- •Patients with abnormal coagulation function or taking anticoagulant drugs
- •Weight < 45 kg or > 80 kg
- •Abnormal parathyroid function, intestinal dysfunction, hypercalcemia (total calcium ion concentration in blood> 2.6 mmol/L)
- •Conditions with high risk of hypercalcemia, such as: Metastatic cancer, Sarcoidosis, Multiple myeloma, Primary hyperparathyroidism
- •Those who are allergic to fish or fish oil
- •Taking beta-blockers, antiepileptic drugs, calcium ion blockers, antidepressants or hormonal preparations in the past month
- •Using vitamin D (> 3000 IU/day), calcium tablets, estrogen drugs, bisphosphonates, and other drugs to treat bone diseases.
结局指标
主要结局
Change of migraine days per month from baseline
时间窗: 12nd week
From questionnaires
次要结局
- Change of Migraine Disability Assessment (MIDAS) score from baseline(12nd week)
- Change of Visual Analogue Scale (VAS) from baseline(12nd week)
- Change of Pittsburgh Sleep Quality Index (PSQI) from baseline(12nd week)
- Change of Hospital Anxiety and Depression Scale (HADS) from baseline(12nd week)
研究者
Chun-pai Yang, MD
Chief, Department of Neurology
Kuang Tien General Hospital