Vitamin K2 and Vessel Calcification in Chronic Kidney Disease Patients (CACSK2)
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ClinicalTrials.gov Identifier: NCT01101698 |
Recruitment Status : Unknown
Verified April 2010 by Medical University of Lodz.
Recruitment status was: Recruiting
First Posted : April 12, 2010
Last Update Posted : April 13, 2010
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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.
Condition or disease | Intervention/treatment | Phase |
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Kidney Diseases Coronary Artery Calcification | Drug: Vitamin K2+10μg cholecalciferol Drug: Vitamin D | Phase 4 |

Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Prevention |
Official Title: | Influence of Vitamin K2 Administration on Vessel Calcification Markers in Patients With Chronic Kidney Disease |
Study Start Date : | June 2009 |
Estimated Primary Completion Date : | December 2010 |
Estimated Study Completion Date : | June 2011 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Vitamin K2, calcification score changes, vitamin D
90 μg vitamin K2+10μg cholecalciferol
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Drug: Vitamin K2+10μg cholecalciferol
Pills of: 90 μg vitamin K2+10μg cholecalciferol once daily during 9 months Drug: Vitamin D Pills of: 10μg cholecalciferol (Vitamin D)once daily during 9 months |
Active Comparator: Vitamin D, calcium score changes
10μg cholecalciferol (vitamin D)
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Drug: Vitamin K2+10μg cholecalciferol
Pills of: 90 μg vitamin K2+10μg cholecalciferol once daily during 9 months |
- Changes in coronary artery calcification score [ Time Frame: 9 months ]
- Changes in common carotid artery intima media thickness [ Time Frame: 9 months ]

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Ages Eligible for Study: | 30 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Subject with chronic kidney disease (creatinine clearance 15-60 ml/min/1,73m2 by Cockroft-Gault formula)
- Patient has a life without dialysis therapy of more than 9 months
- Subject in 30-70 years of age
- Calcium score >10 (as per Agatston scoring system)
Exclusion Criteria:
- Atherosclerosis generalisata (myocardial infarction treated with PTCA - Percutaneous Transluminal Coronary Angioplasty or CABG - Coronary Artery Bypass Graft, symptomatic heart insufficiency, cerebrovascular accident)
- Subject with a history of cardiac abnormalities, including symptomatic or asymptomatic arrhythmias (atrial fibrillation)
- Patient with cardiac pacemaker
- Subject requires long-term use of vitamin K antagonists

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01101698
Poland | |
Department of Nephrology, Hypertension and Kidney Transplantation | Recruiting |
Łódź, Poland, 90-153 | |
Contact: Michał Nowicki, Prof 0048426776709 nefro@wp.pl | |
Contact: Ilona Kurnatowska, MD 0048509293095 ilona.kurnatowska@umed.lodz.pl | |
Principal Investigator: Michał Nowicki, Prof |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Prof Michał Nowicki, Department of Nephrology, Hypertensiology and Kidney Transplantation Medical University of Łódź |
ClinicalTrials.gov Identifier: | NCT01101698 |
Other Study ID Numbers: |
CACSK2 |
First Posted: | April 12, 2010 Key Record Dates |
Last Update Posted: | April 13, 2010 |
Last Verified: | April 2010 |
Vitamin K chronic kidney disease coronary artery calcification intima media thickness |
Kidney Diseases Renal Insufficiency, Chronic Calcinosis Urologic Diseases Renal Insufficiency Calcium Metabolism Disorders Metabolic Diseases Vitamin D Cholecalciferol Vitamins Vitamin K |
Vitamin K 2 Micronutrients Physiological Effects of Drugs Bone Density Conservation Agents Calcium-Regulating Hormones and Agents Antifibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Hemostatics Coagulants |