Vitamin K1 to slow vascular calcification in haemodialysis patients (VitaVasK trial): a rationale and study protocol

Area of Science:

• Cardiovascular Medicine
• Nephrology
• Nutritional Science

Background:

• Patients undergoing hemodialysis (HD) face high cardiovascular mortality due to accelerated vascular calcification (VC).
• Vitamin K is crucial for activating matrix Gla protein (MGP), an inhibitor of VC.
• HD patients commonly have vitamin K deficiency, leading to reduced MGP activity.

Purpose of the Study:

• To evaluate the efficacy of vitamin K1 supplementation in preventing the progression of vascular calcification in hemodialysis patients.
• To assess the impact of vitamin K1 on coronary and aortic calcification.
• To determine if vitamin K1 supplementation can reduce major adverse cardiovascular events and all-cause mortality in this high-risk population.

Main Methods:

• The VitaVasK trial is a prospective, randomized, multicentre study with 348 HD patients.
• Participants receive either standard care or additional 5 mg vitamin K1 orally thrice weekly for 18 months.
• Vascular calcification is assessed using multi-slice computed tomography (MSCT) at baseline and 18 months.

Main Results:

• Primary endpoints include the absolute change in thoracic aortic and coronary artery calcification volume scores at 18 months.
• Secondary endpoints include changes in Agatston score, valve calcification, major adverse cardiovascular events (MACE), and all-cause mortality.
• Long-term follow-up at 3 and 5 years will also record MACE and all-cause mortality.

Conclusions:

• The study aims to identify an inexpensive and safe prophylactic or therapeutic strategy for VC in HD patients.
• Findings may offer a new approach to mitigate cardiovascular risk in this vulnerable population.
• Vitamin K1 supplementation is being investigated as a potential intervention to improve outcomes in hemodialysis patients.