Vitamin K2 Supplementation and Vascular Calcification

Sponsor

Catholic University of Salta (Other)

Overall Status

Completed

CT.gov ID

NCT04539418

Collaborator

(none)

Enrollment

Arms

6.9

Actual Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Renal Disease	Drug: Vitamin K 2	Phase 4

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

Study Design

Study Type:

Interventional

Actual Enrollment :

59 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Prospective, randomized, double-blind studyProspective, randomized, double-blind study

Masking:

Double (Participant, Care Provider)

Masking Description:

Patients are assigned to groups through computer-generated randomization. The investigator will know about the randomization and he will give the care provider the saline or vitamin K2

Primary Purpose:

Prevention

Official Title:

Effect of Vitamin K2 Supplementation on Vascular Calcification in Hemodialysis Patients: a Controlled Randomized Trial.

Actual Study Start Date :

Dec 1, 2016

Actual Primary Completion Date :

Mar 1, 2017

Actual Study Completion Date :

Jun 30, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Vitamn K2 Treated patients Vitamin K2 will be given to patients randomized to ARM 1 three times a week at the end of each dialysis session to prevent it being lost through the ultrafiltration membrane (in order to use the same dialysis access) intravenously to ensure its bioavailability.	Drug: Vitamin K 2 Patients will be monitored during the whole protocol. Other Names: PLACEBO GROUP
Placebo Comparator: Placebo Group Placebo will be given to patients randomized three times a week to ARM 2 at the end of each dialysis session to prevent it being lost through the ultrafiltration membrane (in order to use the same dialysis access) intravenously to ensure its bioavailability.	Drug: Vitamin K 2 Patients will be monitored during the whole protocol. Other Names: PLACEBO GROUP

Arm

Intervention/Treatment

Active Comparator: Vitamn K2 Treated patients

Vitamin K2 will be given to patients randomized to ARM 1 three times a week at the end of each dialysis session to prevent it being lost through the ultrafiltration membrane (in order to use the same dialysis access) intravenously to ensure its bioavailability.

Drug: Vitamin K 2

Patients will be monitored during the whole protocol.

Other Names:

PLACEBO GROUP

Placebo Comparator: Placebo Group

Placebo will be given to patients randomized three times a week to ARM 2 at the end of each dialysis session to prevent it being lost through the ultrafiltration membrane (in order to use the same dialysis access) intravenously to ensure its bioavailability.

Drug: Vitamin K 2

Patients will be monitored during the whole protocol.

Other Names:

PLACEBO GROUP

Outcome Measures

Primary Outcome Measures

EFFECT OF VITAMIN K2 ON VASCULAR CALCIFICATION [6 months]
Changes in the VC (changes in the intimate thickness of carotide artery versus baseline).
CHANGES IN THE PRODUCT PHOSPHORUS CALCIUM [6 months]
Changes in the product phosphorus calcium versus baseline
CHANGES IN PTHi SERUM LEVELS [6 months]
Not significant changes in PTHi serum levels versus baseline

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Men or women ≥18 years old
A period not less than 6 months in HD
Life expectancy ≥ 18 months
Signed informed consent

Exclusion Criteria:

Patients under treatment with phosphorus chelators
Patients who do not want to participate in the study

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Catholic University of Salta

Investigators

Principal Investigator: Rocío Pérez Abud, PhD, Universidad Católica de Salta

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rocío Pérez Abúd, Principal Investigator, Catholic University of Salta

ClinicalTrials.gov Identifier:

NCT04539418

Other Study ID Numbers:

UCASAL-VITK

First Posted:

Sep 7, 2020

Last Update Posted:

Sep 9, 2020

Last Verified:

Sep 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Rocío Pérez Abúd, Principal Investigator, Catholic University of Salta

Hemodialysis patients

Vascular calcification

Vitamin K2

Additional relevant MeSH terms:

Calcinosis

Vascular Calcification

Vitamin K

Vitamin K 2

Study Results

No Results Posted as of Sep 9, 2020