跳至主要内容
临床试验/NCT03311321
NCT03311321Unknown不适用

Vitamin K to Slow Progression of Cardiovascular Disease Risk in Hemodialysis Patients (Vita-K 'n' CKD Study)

Augusta University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年9月13日最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
2
主要终点
Flow-Mediated Dilation (FMD)

研究概览

简要总结

The life span of adults with end-stage renal disease is reduced, and cardiovascular disease (CVD) accounts for approximately half the deaths among those undergoing hemodialysis (HD). Vascular calcification is a key process in the development of atherosclerotic and arteriosclerotic CVD, and contributes significantly to the greater mortality rates and CVD events in HD patients. Recently, there has been growing interest in the vitamin K-dependent matrix Gla protein (MGP) and its role in inhibiting vascular calcification. Animal studies have revealed that the vitamin K-dependent protein MGP may reduce the progression of vascular calcification, possibly by means of improving vascular function. The relationship between MGP and vitamin K lies in the fact that inactive matrix Gla protein requires vitamin K to carboxylate it for its activation. Currently, data in HD patients are scant and equivocal on the effects of vitamin K supplementation on CVD risk outcomes. Therefore, the purpose of this 8-week randomized, placebo-controlled, double-blind clinical trial is to determine whether daily vitamin K supplementation can favorably alter measurements of endothelial function and arterial stiffness in HD patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Chronic Kidney Disease Stages 3 to 5
  • Receiving hemodialysis treatment for at least 3 months
  • Subject understands the study protocol and agrees to comply with it
  • Informed consent documents signed by subject

排除标准

  • Using vitamin supplements containing vitamin K
  • History of metabolic gastrointestinal diseases
  • Subjects presenting chronic degenerative and/or inflammatory diseases
  • Receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters (salicylates, antibiotics)
  • Subjects receiving corticosteroid
  • Use of anticoagulants
  • History of soy allergy
  • Have an unstable medical condition, such as having a life expectancy of less than 6 months in the judgment of the investigator
  • Known sensitivity, intolerance, or other adverse response to study drugs which would prevent compliance with study medication
  • Subjects who have participated in a clinical study more recently than one month before the current study

结局指标

主要结局

Flow-Mediated Dilation (FMD)

时间窗: Change from baseline to 8 weeks

The FMD test is non-invasive assessment of vascular endothelial function.

Pulse Wave Velocity (PWV)

时间窗: Change from baseline to 8 weeks

The PWV test is a non-invasive test of arterial stiffness.

次要结局

  • Prothrombin Time(Change from baseline to 8 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Norman Pollock

Associate Professor, Department of Medicine

Augusta University

研究点 (2)

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