Effect of vitamin K1 supplementation on coronary calcifications in hemodialysis patients: a randomized controlled trial.

Background: Chronic kidney disease (CKD) is associated with several adverse cardiovascular outcomes, including coronary heart disease, heart failure, and arrhythmias. The severity of arterial calcifications predicts the risk of coronary heart disease and increases the risk of premature cardiovascular death. In experimental models, vitamin K1 supplementation appears to reduce coronary artery calcifications.

Methods: In this single-center clinical trial (NCT04247087 on 07/09/2019), we randomized 60 Mexican patients on chronic hemodialysis and a coronary calcification score > 10 Agatston units to receive 10 mg intravenous vitamin K1 or placebo at the end of the hemodialysis session thrice weekly for 12 months. The primary outcome was the progression of coronary artery calcifications as assessed by the absolute change in Agatston and coronary calcium volume scores.

Results: The baseline coronary calcium score was 112.50 (14-2027) Agatston units in the vitamin K1 group and  177 (10-2843); Agatston units in the placebo group (p = 0.71), and after 12 months, the coronary calcium score in the vitamin K1 group was 78.50 (10-1915)  Agatston units in the vitamin K1 group versus  344 (10-3323); Agatston units (p = 0.05) in the placebo group. Progression of coronary calcification was 20.8% in the vitamin K1 group versus 44% in the placebo group, with a relative risk (RR) of 0.45 (CI 95% 0.18-1.15).

Conclusions: In the Mexican hemodialysis cohort enrolled in this study intravenous vitamin K1 supplementation reduced the progression of coronary artery calcifications by 55% compared with placebo over a 12-month follow-up period.