Clinical Trial: Treatment to Reduce Vascular Calcification In Hemodialysis Patients Using Vitamin K

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Treatment to Reduce Vascular Calcification In Hemodialysis Patients Using Vitamin K

Brief 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.

Detailed Summary:
Sponsor: National University Health System, Singapore

Current Primary Outcome: Absolute difference in coronary artery calcium score at 18-month between control and intervention arms [ Time Frame: 18 months ]

Original Primary Outcome: Absolute difference in CAC score at 18-month between control and intervention arms [ Time Frame: 18 months ]

Current Secondary Outcome:

Original Secondary Outcome:

Information By: National University Health System, Singapore

Dates:
Date Received: August 14, 2016
Date Started: July 2016
Date Completion: July 2019
Last Updated: August 16, 2016
Last Verified: August 2016