Study of the Effect of Food Vitamin K2 Intake in Association With a Fermented Dairy Product on Patients Treated With Vitamin K Antagonist (VKA)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- INR
研究概览
简要总结
The objective of the SAFE K study is to demonstrate that in patients treated with the antagonists of vitamin K (VKA), a daily intake of vitamin K2 (75 micrograms/day) as naturally produced by the ferments used in fermented dairy products, does not upset the balance of anticoagulant treatment.Fifty-two patients will be chosen to receive either verum or placebo for four months after a 4-month run-in period.In addition, the study evaluates if regular consumption of vitamin K2 reduce the need of changing the dose of anticoagulation treatment and improve the markers of bone mineralisation.
详细描述
Randomisation of the study subjects will be done by two randomisation lists depending on whether the dose of VKA is high or low. Randomisation will be balanced and stratified depending on the average dose of VKA before the inclusion in order that each arm would have the same number of patients receiving a dose lower than the used anticoagulant treatments.
The level of vitamin K intake will be determined during the study visits using dietary questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •treated with anticoagulants
- •INR range between 2-3
- •TTR (time in therapeutic range)equal or higher 56% during the 4 months before the inclusion
排除标准
- •consumption of significant amounts of products conatining vitamin K
- •regular consumption of dietary supplements susceptible to contain vitamin K
- •milk intolerant or refusing a daily consumption of dairy product
- •previous insufficient earlier therapeutic VKA follow-up
- •cardiac, renal or severe respiratory insufficiency, diseases interfering fat absorption, significant abnormalities in safety parameters, clinically significant thrombotic or hemorrhagic event
结局指标
主要结局
INR
时间窗: change from baseline at four months
prothrombin time
次要结局
- FVII from plasma(change from baseline at two months)
- c/uc osteocalcin ratio(change from baseline at four months)
- FII(change from baseline at four months)
- FVII(change from baseline at four months)
- Plasma vitamin K level(change from baseline at four months)
- Plasma vitamin K levels(change from base-line at two months)