Vitamin K2 Supplementation and Vascular Calcification
Condition: Renal Disease
MeSH terms: Calcinosis; Vascular Calcification
Study type: Interventional
Phase: Phase 4

Summary: 
      Vascular calcification is the leading cause of death in patients with end stage renal disease
      (ESRD) in hemodialysis. The protein matrix Gla vitamin K dependent (MGP) is a potent
      inhibitor of the vascular calcification. Objective: To evaluate the effect of vitamin K2 on
      vascular calcification in patients on hemodialysis. Materials and Methods: A prospective,
      randomized, double-blind study will be performed. The study subjects will be divided into a
      control (1000 µl of saline) or treated group (1000 µl containing 2000 µg of Vitamin K2).
      Vitamin K2 will be administered three times a week intravenously at the end of each dialysis
      session. Blood samples for biochemical determinations and vascular calcification will be
      assessed before and after 6 months of treatment through carotid Doppler ultrasound.
    

Detailed description: 
      This study is designed according to the ethical reference framework for biomedical research
      of the Declaration of Helsinki. Its design is prospective, randomized, double blind. Study
      subjects will be assigned either Arm 1 or control (vial with 1000 μL of saline) or Arm 2 or
      treated group (vial with 1000 μL containing 2000 μg of Vitamin K2). The trial protocol was
      approved by the ethics committee of the Catholic University of Salta and written informed
      consent will be made available to all patients who agree to participate and meet the
      inclusion criteria. Vascular calcification will be evaluated at the beginning of the study to
      determine the presence of vascular calcification and at the end of the study to assess
      changes, if any. The carotid artery examination will be performed with a GE VIVID 5 (GE
      Healthcare, Little Chalfont, Buckinghamshire, UK) with a 7.5 MHz linear probe. The protocol
      used to obtain images is consistent with the recommendations of the American Society of
      Echocardiography. Longitudinal images will be obtained by means of B-mode ultrasound, the
      maximum and the global median intima thickness (EIM) value of the common carotid artery and
      the presence of carotid plaques (defined as isolated and focal areas of the abnormal intima
      that protrude into the lumen more than 1.5 mm or at least 50% of the surrounding total mean
      intimate value). The EIM represents the thickness of the intima, plus the component of the
      mean of the vessel wall; with an automated computerized system of the equipment, on the
      distal wall of both common carotid arteries, 1 cm below the carotid bulb, along a 10 mm long
      straight arterial segment. Patients may be stratified into 3 groups according to the EIM
      value: EIM patients with <0.5 mm are considered disease-free; patients with IMD between 0.6-1
      mm will be considered to be non-significantly affected by the disease; patients with IMD> 1
      mm will be grouped as affected by significant disease (Table 1). Therefore, carotid
      atherosclerosis is considered in the presence of plaques or an EIM> 1 mm. 2.5.3 Table 1.
      Thickness of the intima plus the component of the mean in the wall of a vessel associated or
      not with the presence of vascular calcification.

      EIM VALUE Presence or not of vascular calcification <0,5 mm Patients without vascular
      calcification 0,6-1 mm Patients non-significantly affected by the disease > 1 mm Patients
      significantly affected by the disease
    

Intervention name(s): Vitamin K 2
Intervention type(s): Drug
Intervention description(s): Patients will be monitored during the whole protocol.
Other intervention name(s): PLACEBO GROUP
Intervention MeSH terms: Vitamin K; Vitamin K 2
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, randomized, double-blind study
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: Hemodialysis patients; Vascular calcification; Vitamin K2