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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01101698
Recruitment Status : Unknown
Verified April 2010 by Medical Universtity of Lodz.
Recruitment status was:  Recruiting
First Posted : April 12, 2010
Last Update Posted : April 13, 2010
Information provided by:
Medical Universtity of Lodz

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

  Show Detailed Description

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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

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 ]

Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01101698

Department of Nephrology, Hypertension and Kidney Transplantation Recruiting
Łódź, Poland, 90-153
Contact: Michał Nowicki, Prof    0048426776709   
Contact: Ilona Kurnatowska, MD    0048509293095   
Principal Investigator: Michał Nowicki, Prof         
Sponsors and Collaborators
Medical Universtity of Lodz

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Prof Michał Nowicki, Department of Nephrology, Hypertensiology and Kidney Transplantation Medical University of Łódź Identifier: NCT01101698     History of Changes
Other Study ID Numbers: CACSK2
First Posted: April 12, 2010    Key Record Dates
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
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
Vitamin D
Vitamin K
Vitamin K 2
Vitamin MK 7
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action