The Impact of Vitamin K2 and Inactive Vitamin D Supplementation on Vascular Calcification in Pediatric Patients on Regular Hemodialysis
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Uncarboxylated MGP
研究概览
简要总结
The aim of this study is to assess the effect of supplementation of vitamin K2 (menaquinone, MK-7) and cholecalciferol (inactive vitamin D) on circulating levels of calcification regulators and to assess their safety in pediatric patients on regular hemodialysis patients.
详细描述
Vascular calcification occurs in more than half of chronic renal failure patients, which mainly appears in the large and medium size arteries [3, 4]. It seems that vas¬cular calcification is caused by dynamic imbal-ance of intravascular calcium and phosphorus. However, more and more studies pointed out that vascular calcification were related with local cell's function and biological characteris¬tics.
The aim of this study is to assess the effect of supplementation of vitamin K2 (menaquinone, MK-7) and cholecalciferol (inactive vitamin D) on circulating levels of calcification regulators and to assess their safety in pediatric patients on regular hemodialysis 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
- None
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Vitamin K2 group
15 patients will take 90 ug of vitamin K2 (MK-7) daily in addition to the standard therapy for 4 months.
干预措施: Vitamin K2 (Drug)
Cholecalciferol group
15 patients will take 10 ug of vitamin inactive vitamin D daily in addition to the standard therapy for 4 months.
干预措施: Cholecalciferol (inactive vitamin D) (Drug)
Vitamin K2 and Cholecalciferol group
15 patients will take 90 ug of vitamin K2 (MK-7) in addition 10 ug of vitamin inactive vitamin D to daily in addition to the standard therapy for 4 months.
干预措施: Cholecalciferol (inactive vitamin D) (Drug)
Vitamin K2 and Cholecalciferol group
15 patients will take 90 ug of vitamin K2 (MK-7) in addition 10 ug of vitamin inactive vitamin D to daily in addition to the standard therapy for 4 months.
干预措施: Vitamin K2 and Cholecalciferol (Drug)
结局指标
主要结局
Uncarboxylated MGP
时间窗: 4 months
Measuring serum level of Uncarboxylated MGP as a marker for calcification
Uncarboxylated osteocalcin
时间窗: 4 months
Measuring serum level of Uncarboxylated osteocalcin as a marker for calcification
次要结局
未报告次要终点
研究者
Radwa Maher Abd El Kader El Borolossy
lecturer of clinical pharmacy
Ain Shams University