Treatment to Reduce Vascular Calcification in Hemodialysis Patients Using Vitamin K
Treatment to Reduce Vascular Calcification in Hemodialysis Patients Using Vitamin K
NCT ID: NCT02870829 Phase: PHASE2 Status: COMPLETED Enrollment: 178 Completion: 2022-02
Conditions
Vascular Calcification, Systemic and Arterial Stiffness, Complication of Hemodialysis, Deficiency of Vitamin K2
Interventions
menaquinone-7
Summary
The proposed study will seek to evaluate the prevalence and the progression of vascular calcification in a cohort of maintenance hemodialysis patients in Asian population. It will also evaluate the efficacy of vitamin K 2 supplementation in reducing the progression of vascular calcification in this group of patients.
This will be a single-center randomized, prospective and open-label interventional clinical trial of end stage renal failure patients on hemodialysis.Primary outcome will be absolute difference in coronary artery calcium (CAC) score at 18-month between control and intervention arms. Secondary outcomes will be to compare absolute difference in aortic valve calcification, percentage of patients with regression of coronary artery calcification of at least 10%, absolute difference in aortic and systemic arterial stiffness, mortality from any cause and major adverse cardiovascular events (MACE) over the same period.
Primary Outcome
Absolute difference in coronary artery calcium score at 18-month between control and intervention arms