Finnish Vitamin D Trial (FIND)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,495
- 试验地点
- 2
- 主要终点
- Cardiovascular disease
研究概览
简要总结
The Finnish Vitamin D Trial (FIND) is a randomized, double-blind, placebo-controlled, 5-year supplementation study of the benefits and risks of vitamin D in the primary prevention of cardiovascular (CVD) and cancer among 18000 men 60 years or older and women 65 years or older.
[Edit 25.3.2015: Due to difficulties in recruitment and funding, the study size is approximately 2500 subjects, with a 550 subject subgroup with more detailed examinations]
The participants will be randomized to 3 groups with 6000 in each, with daily supplementation of either: 1) 40 µg/day (1600 IU) of vitamin D3, 2) 80 µg/day (3200 IU) of vitamin D3, or 3) placebo.
[Edit 15.3.2015: The 2500 subjects are randomized in 3 groups, approximately 830 subjects per group.]
Compliance, use of non-study drugs or supplements, diet, development of endpoints, and CVD and cancer risk factors will be assessed by questionnaires. Blood samples will be collected for assessment of effect modification by baseline 25-hydroxyvitamin D, as well as for future ancillary studies of genetic/biochemical hypotheses. Event data will be obtained by record linkage from the national computerized hospitalization registry.
详细描述
More detailed description available upon request.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men 60 years or older
- •Women 65 years or older
排除标准
- •Cardiovascular disease (including myocardial infarction, stroke, transient ischemic attack, angina pectoris, coronary artery bypass grafting, or percutaneous coronary intervention).
- •Cancer (except non-melanoma skin cancer).
- •Any disease or state that raises a vitamin D related safety concern (such as chronic liver, thyroid or kidney disease, hypercalcemia, sarcoidosis or other granulomatous diseases such as active chronic tuberculosis or Wegener's granulomatosis).
- •Use of supplements yielding vitamin D over 20 µg/day or calcium over 1200 mg/day and unwillingness to discontinue the use.
研究组 & 干预措施
Vitamin D3 40
Vitamin D3 40 micrograms (1600 IU) per day
干预措施: Vitamin D3 (Dietary Supplement)
Placebo
Placebo, no Vitamin D3
干预措施: Placebo (Dietary Supplement)
Vitamin D3 80
Vitamin D3 80 micrograms (3200 IU) per day
干预措施: Vitamin D3 (Dietary Supplement)
结局指标
主要结局
Cardiovascular disease
时间窗: 5 years
CVD incidence in VitD arms vs. placebo arm.
Cancer
时间窗: 5 years
Cancer incidence in VitD arms vs.placebo arm
次要结局
未报告次要终点
研究者
Tomi-Pekka Tuomainen
Professor
University of Eastern Finland