Vitamin K2 Supplementation and Vascular Calcification
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| ClinicalTrials.gov Identifier: NCT04539418 |
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Recruitment Status :
Completed
First Posted : September 7, 2020
Last Update Posted : September 9, 2020
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Renal Disease | Drug: Vitamin K 2 | Phase 4 |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 59 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Prospective, 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 : | December 1, 2016 |
| Actual Primary Completion Date : | March 1, 2017 |
| Actual Study Completion Date : | June 30, 2017 |
| Arm | Intervention/treatment |
|---|---|
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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.
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Drug: Vitamin K 2
Patients will be monitored during the whole protocol.
Other Name: PLACEBO GROUP |
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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.
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Drug: Vitamin K 2
Patients will be monitored during the whole protocol.
Other Name: PLACEBO GROUP |
- EFFECT OF VITAMIN K2 ON VASCULAR CALCIFICATION [ Time Frame: 6 months ]Changes in the VC (changes in the intimate thickness of carotide artery versus baseline).
- CHANGES IN THE PRODUCT PHOSPHORUS CALCIUM [ Time Frame: 6 months ]Changes in the product phosphorus calcium versus baseline
- CHANGES IN PTHi SERUM LEVELS [ Time Frame: 6 months ]Not significant changes in PTHi serum levels versus baseline
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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 ClinicalTrials.gov identifier (NCT number): NCT04539418
| Principal Investigator: | Rocío Pérez Abud, PhD | Universidad Católica de Salta |
| Responsible Party: | Rocío Pérez Abúd, Principal Investigator, Catholic University of Salta |
| ClinicalTrials.gov Identifier: | NCT04539418 |
| Other Study ID Numbers: |
UCASAL-VITK |
| First Posted: | September 7, 2020 Key Record Dates |
| Last Update Posted: | September 9, 2020 |
| Last Verified: | September 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
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Hemodialysis patients Vascular calcification Vitamin K2 |
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Calcinosis Vascular Calcification Calcium Metabolism Disorders Metabolic Diseases Vitamin K Vitamin K 2 Vitamins |
Micronutrients Physiological Effects of Drugs Antifibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Hemostatics Coagulants |