Comparative Study Evaluating the Effect of the Administration of Vitamin K1 Versus Vitamin K2 on Vascular Calcification in Dialysis Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- change in serum level of Uncarboxylated MGP
研究概览
简要总结
To evaluate the effect of supplementation of vitamin K2 (menaquinone, MK-7)vs vitamin k1 on circulating levels of calcification regulators and to assess their safety in patients on regular dialysis patients.
详细描述
Vascular calcification has emerged as an independent risk factor for cardiovascular morbidity and mortality, especially in chronic kidney disease .
It has a predictive value of poor prognoses and clinical outcomes in CKD patients such as overall mortality and even poor arteriovenous graft maturation .
Vitamin K is essential for the activation of matrix Gla protein (MGP), a powerful inhibitor of tissue calcification, functional vitamin K deficiency may contribute to high vascular calcification (VC) burden in haemodialysis patients; this is process in which mineral is pathologically deposited in blood vessels, mainly in large elastic and muscular arteries such as the aorta and the coronary, carotid, and peripheral arteries.
it is Prospective, Randomized,Placebo Controlled Study
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both sexes aged between 18-75 years
- •Patients on HD greater than 3 months at least.
- •Stable clinical condition (no hospitalization in the previous 3 months)
排除标准
- •Hypersensitivity to vitamin k
- •Participant in an another clinical trial within the past 4 weeks.
- •Judged to be unsuitable as a subject by the attending physician.
- •Patients taking warfarin
- •Patients with known intestinal malabsorption
- •Patients with hypercoagulable state
研究组 & 干预措施
vitamin k1
vitamin k1 will be given 10 mg thrice a week for 3 months
干预措施: Vitamin K1 (Drug)
vitamin k2
vitamin k2 (menaquinone) will be given 90 ug per day orally
干预措施: Vitamin k2 (Drug)
placebo
placebo will be given daily per oral for 3 months
干预措施: placebo (Other)
结局指标
主要结局
change in serum level of Uncarboxylated MGP
时间窗: change between baseline and after 3 months
Measuring the change in serum level of Uncarboxylated MGP as a marker for calcification
次要结局
- serum calcium level(change between baseline and after 3 months)
- parathyroid hormone(change between baseline and after 3 months)
- serum phosphate level(change between baseline and after 3 months)
研究者
Sarah Farid
clinical professor
Ain Shams University