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
  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:


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:

  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
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:
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:
Kidney Diseases
Arteriosclerosis
Calcinosis
Coronary Artery Disease
Renal Insufficiency, Chronic
Arterial Occlusive Diseases
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 October 21, 2014