Vitamin K2 and Vessel Calcification in Chronic Kidney Disease Patients
Status:
Unknown status
Trial end date:
2011-06-01
Target enrollment:
Participant gender:
Summary
Vessel calcification is a recognised cardiovascular morbidity risk factor in patients with
chronic kidney disease (CKD). Recent reports indicate a significant role of Matrix
Gla-protein (MGP) in decreasing calcification processes. MGP is excretion protein whose
mechanism of action is not yet fully explained and which to be activated requires
phosphorylation and carboxylation where cofactor is vitamin K. These observations indicate
that shortage of vitamin K is a significant risk factor for the development of vessel
calcification. Another calcification risk factor in CKD patients are calcium-phosphate
disturbances and insufficiency of vitamin D3 which in physiological concentration stimulates
MGP transcription. The aim of this study is estimation of influence of vitamin K2
administration over the period of 9 months on vessel calcification in 3.- 5. stage CKD
patients.
It is a prospective, randomised double-blind study carried out in parallel groups. 60
patients with CKD (GFR 15-60 ml/min) with calcium score >10 (Agatston scoring system) will be
qualified for the study. On the basis of randomised selection, patients will be divided into
two groups: 30 patients will be given 90 μg vitamin K2 + 10 μg and cholecalciferol 30
patients will be given only 10 μg cholecalciferol. After a 9-month treatment the image
diagnostic will be carried out in order to estimate the degree of vessel calcification.
Phase:
Phase 4
Details
Lead Sponsor:
Medical University of Lodz Medical Universtity of Lodz
Treatments:
Cholecalciferol Ergocalciferols Vitamin D Vitamin K Vitamin K 2 Vitamin MK 7 Vitamins