Efficacy of Vitamin D and Calcium Supplementation on the Prevention of Recurrences in Benign Paroxysmal Positional Vertigo: A Prospective Multicenter Randomized Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,050
- 试验地点
- 1
- 主要终点
- Recurrence frequency of benign paroxysmal positional vertigo
研究概览
简要总结
The purpose of this study is to determine whether the supplementation of vitamin D and calcium prevents recurrences of benign paroxysmal positional vertigo in patients with vitamin D deficiency/insufficiency.
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
- None
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
- •age 18 years or older
- •brief episodes of vertigo induced by head motion
- •a typical positioning nystagmus characteristic of BPPV
- •no supplementation of vitamin D or calcium at the time of recruitment
- •informed consent to participate in this study
- •subject treated by repositioning maneuver
排除标准
- •other identifiable disorders of the central nervous system
- •supplementation of vitamin D or calcium at the time of recruitment
- •pregnancy
- •a history of an allergic reaction, or a medically significant adverse reaction to the investigational product
- •contraindication to cholecalciferol and calcium carbonate
研究组 & 干预措施
Vitamin D and calcium supplement
干预措施: 400IU cholecalciferol and 500mg of elemental calcium as calcium carbonate (Drug)
结局指标
主要结局
Recurrence frequency of benign paroxysmal positional vertigo
时间窗: Up to 1 year
The intervention group will receive tablets containing 400IU cholecalciferol and 500mg of elemental calcium as calcium carbonate twice daily (CAVID CHEWABLE TAB, Takeda Pharmaceuticals) for 12 months when the initial serum vitamin D is decreased. The compliance will be determined by the percentage of consumed tablets from the delivered tablets during the follow-up period. Discontinuation of the supplementation due to adverse effects or other reasons will be registered using the telephone interview together with the primary outcome date. Participants in the control group will not have any intervention or placebo. They will not be allowed to take vitamin D or calcium as supplements during the follow-up. The primary outcome measure is the recurrence of BPPV after one year. Data on recurrences will be collected using a monthly telephone interview, and the patients will be asked to visit the clinic whenever they have the symptoms of BPPV. All the recurrences of BPPV will be included.
次要结局
- Changes in serum 25-hydroxy vitamin D level(Up to 1 year)
- Falling frequency(Up to year)
- Fracture frequency(Up to 1 year)
- Quality of life(Up to 1 year)
- Recurrence rate of benign paroxysmal positional vertigo(Up to 1 year)
研究者
Ji-Soo Kim
Professor and Chairman, Department of Neurology
Seoul National University Bundang Hospital