Vitamin K Containing Nutritional Supplement for Activation of Matrix-GIa-proteins (MGP) and Inhibition of Aortic Valve Calcification Process
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Decrease of aortic valve calcification by activation of the calcification inhibiting protein MGP by means of additional intake of vitamin K
研究概览
简要总结
In this mono-center,open,three-armes, controlled, randomized phase I study the progress of aortic valve calcification with and without vitamin K supplementation will be investgated. This will be done by means of measurements of concentrations from osteocalcine and MPG in blood serum, echocardiography, cardiac computed tomography and cardiac MRI
详细描述
Patients will be allocated to two groups with either
- additional intake of 2 mg vitamin k1 daily
- controll group without additional intake of Vitamin K
Treatment group a will include 100 patients, the controll group should include 100 patients. None of all patients should require renal dialysis.
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
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aortic valve calcification,verified by echocardiography
排除标准
- •chronic or acute intestinal diseases
- •terminal renal failure
- •allergic reaction on soya containing products
- •recent additional intake of vitamin K
- •oral anticoagulation with vitamin K antagonists (Marcoumar)
- •systemic therapy with corticosteroids
- •anamnestic venous thrombosis (pelvet or legs)or embolization of lung arteria
- •pregnant or breastfeeding women
- •persons without mental ability or capacity to understand and follow the instructions of the investigator
- •women of childbearing age without safe contraceptional devices
研究组 & 干预措施
1
100 patients daily additional intake of 2mg vitamin k1
干预措施: Vitamin K supplementation (Dietary Supplement)
2
100 patients no additional intake of vitamin K
干预措施: Vitamin K supplementation (Dietary Supplement)
结局指标
主要结局
Decrease of aortic valve calcification by activation of the calcification inhibiting protein MGP by means of additional intake of vitamin K
时间窗: 18 months
次要结局
- progression of diastolic and systolic dysfunction in the three treatment groups(18 months)