NCT02517580已完成2 期
Vitamin K2 Supplementation and Effect on Arterial Stiffness Progression in the Renal Transplant Population
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Reduction From Baseline in Carotid-femoral Pulse Wave Velocity at 8 Weeks
研究概览
简要总结
This study is a single arm, single center clinical trial that aims to evaluate the effect of 8 weeks of vitamin K2 replacement (360 mcg/day) on the progression of arterial stiffness in stable renal transplant patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Functional renal graft
- •Stable renal function for at least 3 months prior to enrollment
排除标准
- •History of thrombotic events
- •Diagnosed coagulopathy
- •Cardiovascular event in the past month prior to enrollment
- •Current or planned pregnancy
- •Lactation
- •Soy allergy
- •Concomitant or recent (past 6 months) use of supplements that contain vitamin K
- •Warfarin treatment
- •Known intestinal malabsorption or hypomotility syndromes
研究组 & 干预措施
Vitamin K2 (MK7)
Experimental
Vitamin K2 (MK7) 360 mcg/day PO once daily for 8 weeks
干预措施: Vitamin K2 (MK7) (Dietary Supplement)
结局指标
主要结局
Reduction From Baseline in Carotid-femoral Pulse Wave Velocity at 8 Weeks
时间窗: 8 weeks
次要结局
- Change From Baseline in Augmentation Index by Ambulatory Hemodynamic Measurement (Mobil-O-Graph) at 8 Weeks(8 weeks)
- Change From Baseline in Blood Concentration of Dephosphorylated-uncarboxylated Matrix Gla Protein (Dp-ucMGP) at 8 Weeks(8 weeks)
- Change From Baseline in Central Pressure by Ambulatory Hemodynamic Measurement (Mobil-O-Graph) at 8 Weeks(8 weeks)
研究者
Sola Aoun Bahous, M.D. Ph.D.
Associate Professor of Medicine, Division of Nephrology and Transplantation
Lebanese American University
研究点 (1)
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