Vitamin D AND Cardiovascular Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- insulin secretion and sensitivity as assessed by an hyperglycemic clamp
研究概览
简要总结
In this study the investigators want to compare glucose handling (insulin secretion and insulin sensitivity) in 100 persons with low and 50 persons with normal-high levels of vitamin D, using a hyperglycemic clamp technique, were sugar is given intravenously for 3 hours in order to keep the blood sugar level at 10 mmol/L. Those with low vitamin D levels will be randomized to treatment with vitamin D3 (cholecalciferol) 40 000 IU/week or placebo for 6 months before a new clamp is performed.
The study hypothesis is that persons with low vitamin D levels have impaired glucose handling which might be improved by vitamin D supplementation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •generally: Subjects are recruited from the 6th Tromsø Study
- •cases: serum 25-hydroxyvitamin D-levels below the 10 percentile; low levels confirmed with new serum analyses.
- •controls: serum 25-hydroxyvitamin D levels 80-95 percentile, normal-high levels confirmed with new serum analyses.
排除标准
- •myocardial infarction or apoplexia
- •active cancer during last 5 years
- •history of kidney stone
- •pregnancy or premenopausal without safe anticonception
- •primary hyperparathyroidism
- •systolic blood pressure >175 or diastolic blood pressure >105
结局指标
主要结局
insulin secretion and sensitivity as assessed by an hyperglycemic clamp
时间窗: 6 months
intraocular pressure
时间窗: 6 months
次要结局
- telomer length(6 months)
- 25-hydroxyvitamin D and 1,25-dihydroxyvitamin D-levels(6 months)
- serum calcium, PTH, phosphate(6 months)
- inflammatory markers and lipids(6 months)