CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 59 enrolled
Drug / intervention
Vitamin K 2drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04539418
NCT04539418Phase 4Completed

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

Catholic University of Salta·interventional·Posted Sep 7, 2020·Updated Sep 9, 2020

In Brief

A Phase 4 clinical trial evaluating Vitamin K 2 for Renal Disease. Completed, enrolled 59 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRenal Disease
Countries--
Collaborators--

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedSep 7, 2020
Enrollment StartDec 1, 2016
Primary CompletionMar 1, 2017
Study CompletionJun 30, 2017
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 5.8 years ago

Interventions

Vitamin K 2drug

Patients will be monitored during the whole protocol.