Randomized Prospective Open Interventional Multi-centre Study on Finding the Optimal Dose of Vitamin K2 Supplements for Hemodialysis Patients
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
- 否
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
Rogier Caluwe
MD
Onze Lieve Vrouw Hospital
