Food Supplementation With Vitamin K2 to Activate MGP as an Endogenous Inhibitor of Vascular Calcification in Hemodialysis Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 6
- 主要终点
- Reduction of plasma levels of noncarboxylated MGP
研究概览
简要总结
Vascular calcification (VC) is a predictor of cardiovascular morbidity and mortality. Hemodialysis (HD) patients suffer from severe vascular calcifications. Matrix Gla protein (MGP) is a central calcification inhibitor of the arterial wall and its activity depends on vitamin K-dependent γ-glutamate carboxylation. Noncarboxylated MGP, formed as a result of vitamin K deficiency, is associated with cardiovascular disease. Recent studies pointed towards poor vitamin K status in HD patients. We therefore aim to investigate whether daily vitamin K2 (MK-7) supplementation improves the bioactivity of vitamin K-dependent proteins in HD patients as assessed by circulating dephospho-noncarboxylated MGP (dp-ucMGP), noncarboxylated osteocalcin (ucOC) and noncarboxylated prothrombin (ucFII; PIVKA-II).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
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
- •> 18 years of age
- •minimum of 3 months of hemodialysis
- •written consent
排除标准
- •chronic or acute bowel disease
- •soy bean allergy
- •active Vitamin K Supplementation
- •oral anticoagulation with vitamin K Antagonists (coumarins)
- •systemic therapy using steroids
- •positive history for thrombosis or embolism
- •pregnancy
结局指标
主要结局
Reduction of plasma levels of noncarboxylated MGP
时间窗: after 6 weeks of supplementation
Noncarboxylated MGP levels \[pmol/L\] will be determined from plasma samples by a non-commercial ELISA. Plasma samples will be obtained each week of the six-week treatment period and compared to baseline values.
Reduction of plasma levels of noncarboxylated osteocalcin
时间窗: after 6 weeks of supplementation
Noncarboxylated osteocalcin levels \[ng/ml\] will be determined from plasma samples by a commercial ELISA. Plasma samples will be obtained each week of the six-week treatment period and compared to baseline values.
Reduction of plasma levels of inactive prothrombin (PIVKA-II)
时间窗: after 6 weeks of supplementation
PIVKA-II levels \[ng/ml\] will be determined from plasma samples by a commercial ELISA. Plasma levels at the end of the six-week treatment period will be compared to baseline levels.
次要结局
- increase of plasma levels of carboxylated MGP(after 6 weeks of supplementation)
- increase of plasma levels of carboxylated osteocalcin(after 6 weeks of supplementation)