Vitamin K2 and Vessel Calcification in Chronic Kidney Disease Patients (CACSK2)
Recruitment status was Recruiting
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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 |
- Changes in coronary artery calcification score [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
- 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 |
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| 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 | |
More Information
Publications:
| 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:
|
Vitamin K Vitamin K 2 Calcinosis Kidney Diseases Renal Insufficiency, Chronic Kidney Failure, Chronic Coronary Artery Disease Arteriosclerosis Calcium Metabolism Disorders Metabolic Diseases Urologic Diseases Renal Insufficiency Coronary Disease Myocardial Ischemia Heart Diseases |
Cardiovascular Diseases Arterial Occlusive Diseases Vascular Diseases Cholecalciferol Vitamin D Ergocalciferols Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Bone Density Conservation Agents Antifibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013