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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified April 2010 by Medical Universtity of Lodz.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Medical Universtity of Lodz

ClinicalTrials.gov Identifier:

NCT01101698

First received: April 9, 2010

Last updated: April 12, 2010

Last verified: April 2010

History of Changes

Purpose

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	Intervention	Phase
Kidney Diseases Coronary Artery Calcification	Drug: Vitamin K2+10μg cholecalciferol Drug: Vitamin D	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention
Official Title:	Influence of Vitamin K2 Administration on Vessel Calcification Markers in Patients With Chronic Kidney Disease

Resource links provided by NLM:

MedlinePlus related topics: Chronic Kidney Disease Kidney Diseases Vitamin D Vitamin K

Drug Information available for: Menadione Cholecalciferol Vitamin D

U.S. FDA Resources

Further study details as provided by Medical Universtity of Lodz:

Primary Outcome Measures:

Changes in coronary artery calcification score [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Changes in common carotid artery intima media thickness [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]


Estimated Enrollment:	60
Study Start Date:	June 2009
Estimated Study Completion Date:	June 2011
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Show Detailed Description

Eligibility


Ages Eligible for Study:	30 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01101698

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

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.


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
Study First Received:	April 9, 2010
Last Updated:	April 12, 2010
Health Authority:	Poland: Ethics Committee

Keywords provided by Medical Universtity of Lodz:


Vitamin K chronic kidney disease coronary artery calcification intima media thickness

Additional relevant MeSH terms:


Calcinosis Coronary Artery Disease Kidney Diseases Renal Insufficiency, Chronic Arterial Occlusive Diseases Arteriosclerosis Calcium Metabolism Disorders Cardiovascular Diseases Coronary Disease Heart Diseases Metabolic Diseases Myocardial Ischemia Renal Insufficiency Urologic Diseases Vascular Diseases	Cholecalciferol Ergocalciferols Vitamin D Vitamin K Vitamin K 2 Vitamin MK 7 Vitamins Antifibrinolytic Agents Bone Density Conservation Agents Coagulants Fibrin Modulating Agents Growth Substances Hematologic Agents Hemostatics Micronutrients

ClinicalTrials.gov processed this record on March 03, 2015

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