Treatment to Reduce Vascular Calcification in Hemodialysis Patients Using Vitamin K

• Status: Active, not recruiting
• Trial end date: 2020-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National University Health System, Singapore
• Collaborators: National Medical Research Council (NMRC), Singapore; Nattopharma ASA
• Treatments: Vitamin K; Vitamin K 2; Vitamin MK 7; Vitamins

Criteria

Inclusion Criteria:

1. Age ≥ 45 years and less than 80 years

2. At least 12 months on Hemodialysis

3. Coronary artery calcium score of ≥ 30 in the baseline Multislice Computed Tomography

4. Able to give informed consent

5. Life expectancy of at least18 months

Exclusion Criteria:

1. History of thrombosis in the last 6 months except vascular access thrombosis

2. Need for vitamin K antagonists therapy at baseline or in the 3 months prior to baseline

3. Presence of significant gut disease (inflammatory bowel disease, short-bowel syndrome)

4. Liver dysfunction

5. Alcohol or drug abuse

6. Presence of coronary stent or have undergone coronary artery bypass grafting

7. Women who are pregnant or breast feeding,

8. Those who are fearful of confined space and cannot lie still for Multislice Computed Tomography

9. Lack of safe contraceptive measures.

10. Those who had parathyroid surgery done.

11. Those with parathyroid hormone (PTH) > 150 pmol/l

12. Patient taking multivitamins containing vitamin K

13. Patient allergic to soy based products