Randomized Controlled Clinical Trial of the Effect of Treatment with Vitamin K2 on Vascular Calcification in Hemodialysis Patients (Trevasc-HDK)

• Published in: Kidney international reports 2023-09, Vol.8 (9), p.1741-1751
• Main Authors: Haroon, Sabrina, Davenport, Andrew, Ling, Lieng-Hsi, Tai, Bee-Choo, Teo, Lynette-Li-San, Schurgers, Leon, Chen, Zhaojin, Shroff, Rukshana, Fischer, Dagmar-Christiane, Khatri, Priyanka, Low, Sanmay, Tan, Jia-Neng, Chua, Horng-Ruey, Teo, Boon-Wee, Ong, Ching-Ching, Subramanian, Srinivas, Yeo, Xi-Er, Wong, Weng-Kin, Lau, Titus-Wai-Leong
• Format: Article
• Language: English
• Subjects: aortic augmentation index; carotid-femoral pulse wave velocity; Clinical Research; dephosphorylated undercarboxylated MGP; hemodialysis; vascular calcification; vitamin K
• ISSN: 2468-0249; 2468-0249
• DOI: 10.1016/j.ekir.2023.06.011

Vitamin K deficiency among patients on hemodialysis (HD) affects the function of matrix GLA protein (MGP), a potent vitamin K-dependent inhibitor of vascular calcification (VC). We conducted a single-center randomized controlled trial (RCT) on maintenance HD patients to examine if vitamin K2 supplementation can reduce progression of coronary artery calcification (CAC) over an 18-month study period. Patients were randomized to vitamin K2 group receiving menaquinone-7360 μg 3 times/wk or control group. The primary outcome was CAC scores at the end of the study period. The secondary outcomes were aortic valve calcification (AVC), carotid-femoral pulse wave velocity (cfPWV), aortic augmentation index (AIx), dephosphorylated undercarboxylated MGP (dp-ucMGP) levels, major adverse cardiac events (MACE), and vascular access events. Of the 178 patients randomized, follow-up was completed for 138 patients. The CAC scores between the 2 groups were not statistically different at the end of 18 months (relative mean difference [RMD] 0.85, 95% CI 0.55–1.31). The secondary outcomes did not differ significantly in AVC (RMD 0.82, 95% CI 0.34–1.98), cfPWV (absolute mean difference [AMD] 0.55, 95% CI −0.50 to 1.60), and AIx (AMD 0.13, 95% CI −3.55 to 3.80). Supplementation with vitamin K2 did reduce dp-ucMGP levels (AMD −86, 95% CI −854 to −117). The composite outcome of MACE and mortality was not statistically different between the 2 groups (Hazard ratio = 0.98, 95% CI 0.50–1.94). Our study did not demonstrate a beneficial effect of vitamin K2 in reducing progression of VC in this population at the studied dose and duration. [Display omitted]