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临床试验/NCT01675206
NCT01675206已完成3 期

Randomized Prospective Open Interventional Multi-centre Study on Finding the Optimal Dose of Vitamin K2 Supplements for Hemodialysis Patients

Rogier Caluwe0 个研究点目标入组 165 人开始时间: 2011年5月1日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
165
主要终点
percentage of reduction in dp-ucMGP after 8 weeks of Vitamin K2 supplementation

研究概览

简要总结

This study aims at finding the optimal dose of Vitamin K2 supplementation in hemodialysis patients.

详细描述

During the past few years evidence is emerging for a role of Matrix Gla Protein (MGP) as one of the most powerful inhibitors of vascular calcification (Shurgers LJ et al. Thromb Haemost 2008; 100: 593-603). MGP is a Vitamin K dependent protein. This means that he presence of Vitamin K2 is required to promote the gamma-carboxylation process turning MGP in its carboxylated and active form. Recent data show that dp-uc MGP correlates well with Vitamin K status (Cranenburg CM et al. Thrombosis and Haemostasis 2010; 104/4: 811-822).

It is widely recognized that patients with renal insufficiency treated with hemodialysis are prone to accelerated vascular calcification resulting in excess cardiovascular morbidity and mortality (Goodman WG et al. N Engl J Med 2000; 342: 1478-1483).

Consequently, the administration of Vitamin K2 supplements may protect hemodialysis patients against accelerated vascular calcification by enhancing the gamma-carboxylation process of MGP. However, the optimal dose of Vitamin K2 required to achieve these results remains to be defined

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
Single (Participant)

入排标准

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

入选标准

  • age ≥18 year
  • signed informed consent
  • end stage renal disease treated with chronic hemodialysis at least three times a week

排除标准

  • coumarin treatment
  • known intestinal malabsorption
  • inability to take oral medication
  • medical conditions with a considerable probability for death within 2 months

结局指标

主要结局

percentage of reduction in dp-ucMGP after 8 weeks of Vitamin K2 supplementation

时间窗: 8 weeks

this study aims at verifying whether higher doses of Vitamin K2 supplementation result in an increased reduction in dp-ucMGP

次要结局

  • Assessment of adverse reactions associated with Vitamin K2 intake(8 weeks)

研究者

发起方
Rogier Caluwe
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Rogier Caluwe

MD

Onze Lieve Vrouw Hospital

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