Vitamin K2 and Vessel Calcification in Chronic Kidney Disease Patients (CACSK2)

Study Description

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Brief 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.

Condition or disease	Intervention/treatment	Phase
Kidney Diseases; Coronary Artery Calcification	Drug: Vitamin K2+10μg cholecalciferol; Drug: Vitamin D	Phase 4

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Study Design

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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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Active Comparator: Vitamin K2, calcification score changes, vitamin D; 90 μg vitamin K2+10μg cholecalciferol	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)	Drug: Vitamin K2+10μg cholecalciferol; Pills of: 90 μg vitamin K2+10μg cholecalciferol once daily during 9 months

Outcome Measures

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Primary Outcome Measures :

1. Changes in coronary artery calcification score [ Time Frame: 9 months ]

Secondary Outcome Measures :

1. Changes in common carotid artery intima media thickness [ Time Frame: 9 months ]

Eligibility Criteria

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Ages Eligible for Study:	30 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

1. Subject with chronic kidney disease (creatinine clearance 15-60 ml/min/1,73m2 by Cockroft-Gault formula)
2. Patient has a life without dialysis therapy of more than 9 months
3. Subject in 30-70 years of age
4. Calcium score >10 (as per Agatston scoring system)

Exclusion Criteria:

1. Atherosclerosis generalisata (myocardial infarction treated with PTCA - Percutaneous Transluminal Coronary Angioplasty or CABG - Coronary Artery Bypass Graft, symptomatic heart insufficiency, cerebrovascular accident)
2. Subject with a history of cardiac abnormalities, including symptomatic or asymptomatic arrhythmias (atrial fibrillation)
3. Patient with cardiac pacemaker
4. Subject requires long-term use of vitamin K antagonists

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

Medical Universtity of Lodz

More Information

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Publications:

Pilkey RM, Morton AR, Boffa MB, Noordhof C, Day AG, Su Y, Miller LM, Koschinsky ML, Booth SL. Subclinical vitamin K deficiency in hemodialysis patients. Am J Kidney Dis. 2007 Mar;49(3):432-9.

Schurgers LJ, Cranenburg EC, Vermeer C. Matrix Gla-protein: the calcification inhibitor in need of vitamin K. Thromb Haemost. 2008 Oct;100(4):593-603. Review.

Cranenburg EC, Vermeer C, Koos R, Boumans ML, Hackeng TM, Bouwman FG, Kwaijtaal M, Brandenburg VM, Ketteler M, Schurgers LJ. The circulating inactive form of matrix Gla Protein (ucMGP) as a biomarker for cardiovascular calcification. J Vasc Res. 2008;45(5):427-36. doi: 10.1159/000124863. Epub 2008 Apr 10.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Kurnatowska I, Grzelak P, Masajtis-Zagajewska A, Kaczmarska M, Stefańczyk L, Vermeer C, Maresz K, Nowicki M. Effect of vitamin K2 on progression of atherosclerosis and vascular calcification in nondialyzed patients with chronic kidney disease stages 3-5. Pol Arch Med Wewn. 2015;125(9):631-40. Epub 2015 Jul 15.

Responsible Party:	Prof Michał Nowicki, Department of Nephrology, Hypertensiology and Kidney Transplantation Medical University of Łódź
ClinicalTrials.gov Identifier:	NCT01101698 History of Changes
Other Study ID Numbers:	CACSK2
First Posted:	April 12, 2010
Last Update Posted:	April 13, 2010
Last Verified:	April 2010

Keywords provided by Medical Universtity of Lodz:

Vitamin K; chronic kidney disease; coronary artery calcification; intima media thickness

Additional relevant MeSH terms:

Kidney Diseases; Renal Insufficiency, Chronic; Calcinosis; Arteriosclerosis; Coronary Artery Disease; Urologic Diseases; Renal Insufficiency; Calcium Metabolism Disorders; Metabolic Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases	Vitamins; Vitamin D; Ergocalciferols; Cholecalciferol; Vitamin K; Vitamin K 2; Vitamin MK 7; Micronutrients; Growth Substances; Physiological Effects of Drugs; Bone Density Conservation Agents; Antifibrinolytic Agents; Fibrin Modulating Agents; Molecular Mechanisms of Pharmacological Action; Hemostatics