TABLE 2.
A summary of ongoing clinical trials on the effect of Vitamin K supplementation to delay or even stop vascular calcification in CKD population.
References | Registration | Study design | Population | Sample size | Vitamin K |
Control | Intervention | Duration | VC related outcomes | |
Type | Dose | |||||||||
Caluwe et al. (25) | NCT02610933 | Randomized, open-label study | HD | 117 | MK-7 | 2,000 μg Tiw | Rivaroxaban | 18 m | Calcification score of coronary arteries, thoracic aortic and valve; PWV | |
Haroon et al. (27) | NCT02870829 | Randomized, open-label study | HD | 200 | MK-7 | 360 μg Tiw | Null | 18 m | Coronary artery calcium score | |
Krueger et al. (29) | EudraCT No.: 2010-021264-14 | Prospective, randomized, parallel, open-label, multicenter trial | HD | 348 | Phylloquinone | 5 mg Tiw | Null | VK1 | 18 m | Calcification volume score of thoracic aortic and coronary artery |
Oyama et al. (30) | UMINID000011490 | Prospective, randomized, parallel group, multicenter trial | HD | 200 | Menatetrenone | 45 mg Qd | Null | VK2 | 24 m | Abdominal aortic Agatston score |
NCT (33) | NCT04900610 | Multi-center, placebo-controlled, randomized, open-label trial | PD | 120 | MK-7 | 1 mg Qd | Placebo | VK2 | 1.5 y | PWV |
NCT (34) | NCT04539418 | Prospective, randomized, double-blind study | HD | 59 | Vitamin K2 | 2,000 μg Tiw IV | Saline | VK2 | 6 m | Intimate thickness of carotid artery |
NCT (35) | NCT04477811 | Randomized, triple-blind parallel study | HD | 40 | Menatetrenone, phytonadione | VK1 10 mg Tiw; VK2 90 μg Qd | Placebo | VK1; VK2 | 3 m | Serum ucMGP |
NCT (36) | NCT03311321 | Randomized, quadruple-blind parallel study | HD | 60 | MK-7 | 360 μg Qd | Placebo | VK2 | 8 w | FMD, PWV |
NCT (37) | NCT02976246 | Randomized, quadruple-blind parallel study | HD or PD | 123 | MK-7 | 360 μg Qd | Placebo | VK2 | 2 y | Coronary vascular and -valve calcification |
NCT (38) | NCT02278692 | Randomized, quadruple-blind parallel study | CUA | 26 | Phytonadione | 10 mg Tiw | Placebo | VK1 | 12 w | Circulating MGP, area of CUA |
NCT (39) | NCT01742273 | Randomized, open-label study | HD | 63 | Phylloquinone | 5 mg Tiw | Null | VK1 | 18 m | Calcification score of coronary arteries, thoracic aortic and valve |
CUA, calcific uremic arteriolopathy; FMD, Flow-Mediated Dilation; HD, hemodialysis; m, month; PD, peritoneal dialysis; PWV, Pulse Wave Velocity; VC, vascular calcification; VK1, vitamin K1; VK2, vitamin K2; w, week; y, year.