The Role of Vitamin D Plasma Levels in the Development of Headache
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Plasma levels of vitamin D using high performance liquid chromatography
研究概览
简要总结
To date there are conflicting data concerning a correlation between plasma vitamin D levels and headache.
The aim of this study was to evaluate plasma vitamin D levels in patients with headache admitted to the Center of Headache of Pugliese Ciaccio Hospital.
详细描述
Several papers suggest that inflammation is able to induces both headache and low levels of vitamin D. However, to date a correlation between plasma vitamin D levels and headache has not been demonstrated. Recently we documented that low levels of Vitamin D are related to a low statin efficacy. In this study we will evaluate the plasma levels of vitamin D in patients with headache admitted to the Center of Headache of Pugliese Ciaccio Hospital.
Moreover it will be also evaluated:
- the correlation between efficacy and safety of drugs used in headache treatment and plasma vitamin D levels.
- the role of vitamin D supplementation on both headache symptoms and drug effects.
Plasma vitamin D levels in patients with headache will be evaluated respect to patients without headache.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •acute or chronic headache diagnosed according to the clinical and radiological criteria of the headache Association
排除标准
- •allergy to drugs,
- •progressive serious medical conditions (such as cancer, AIDS or end-stage renal disease)
- •renal diseases (serum creatinine concentration more than 1.2 times the upper limit of the normal range according to the central laboratory definition reference values)
- •liver dysfunction (serum alanine or aspartate transaminase concentrations more than 1.5 times the upper limit of normal range according to the central laboratory definition reference values)
- •alcohol consumption (>3 alcoholic beverages daily)
- •substance abuse
- •inability to give written informed consent
- •actual or recent (3-month) treatment with corticosteroids, indomethacin or other antinflammatory drugs.
- •secondary headache
研究组 & 干预措施
control group
Patients without headache. No drugs will be administered
Acute Headache
Patients without chronic headache but with an history of headache < 6 months. Vitamin D supplementation (from 400 iU/day up to 1600 IU/day) will be administered.
干预措施: vitamin D supplementation (Dietary Supplement)
Chronic headache with drug overuse
Patients with headache > 6 months related to drug treatment, i.e. non steroidal antinflammatory drugs. Vitamin D supplementation (from 400 iU/day up to 1600 IU/day) will be administered.
干预措施: vitamin D supplementation (Dietary Supplement)
Chronic Headache
Patients with headache > 6 months. Vitamin D supplementation (from 400 iU/day up to 1600 IU/day) will be administered.
干预措施: vitamin D supplementation (Dietary Supplement)
结局指标
主要结局
Plasma levels of vitamin D using high performance liquid chromatography
时间窗: up to 24 weeks
次要结局
- Headache pain through the Visual Analog Scale (VAS)(up to 24 weeks)
研究者
Luca Gallelli
MD
University of Catanzaro