The Effects of Vitamin K2 Supplementation on the Progression of Coronary Artery Calcification
试验速览
- 阶段
- 不适用
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Coronary Artery Calcification-score progression
研究概览
简要总结
Both Coronary Artery Calcification (CAC)and its annual progression are a strong predictors of cardiovascular events. The development of arterial calcification results from imbalance between calcification promoting and inhibiting factors. An important inhibitor of calcification is Matrix Gla Protein (MGP): a protein present in the vascular wall where it is synthesized by Vascular Smooth Muscle Cells (VSMC). MGP requires Vitamin K-mediated carboxylation to function properly. Deficiency of Vitamin K has been demonstrated to cause arterial calcification and a diet containing large amounts of Vitamin K2 was associated with lower CAC and cardiovascular risk. In animal studies, active supplementation of Vitamin K2 caused regression of existing arterial calcification. Therefore, the aim of this randomized, double-blind, placebo-controlled clinical trial is to investigate whether daily supplementation of Vitamin K2 (Menaquinone-7) to patients with established CAC will lead to a decreased progression-rate of CAC after 24 months of follow-up in comparison to placebo.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Baseline Coronary Computed Tomographic Angiography (CCTA) of sufficient quality
- •Baseline Agatston calciumscore 100 - 400
排除标准
- •Baseline-scan of insufficient quality
- •Heart rate greater than 70 beats per minute during first scan.(despite adequate treatment with metoprolol)
- •Chronic or paroxysmal Atrial Fibrillation
- •Presence or scheduled coronary revascularization procedure
- •History of myocardial infarction or stroke.
- •Presence of Diabetes Mellitus.
- •Known kidney disease or a Glomerular Filtration Rate (GFR)MDRD < 60 ml/min/1.73m2
- •Malignant disease (exception: treated basal-cell or squamous cell carcinoma).
- •Use of Vitamin K antagonists.
- •A life-expectancy < 2 years
- •Pregnancy or wish to become pregnant in the near future.
研究组 & 干预措施
Vitamin K2 supplementation
干预措施: Menaquinone-7 (Vitamin K2) (Dietary Supplement)
Placebo control
干预措施: Placebo capsules (Other)
结局指标
主要结局
Coronary Artery Calcification-score progression
时间窗: 12 and 24 months
次要结局
- Arterial Stiffness measured by Carotid-Femoral Pulse-Wave Velocity(0, 12 and 24 months)
- Carotid Intima Media Thickness(0, 12 and 24 months)