Dose Defining Study for the Administration of Vitamin K2 Supplements in Hemodialysis Patients

Vascular Calcification Clinical Trial

Official title: Randomized Prospective Open Interventional Multi-centre Study on Finding the Optimal Dose of Vitamin K2 Supplements for Hemodialysis Patients

Status Completed

Clinical Trial Summary

This study aims at finding the optimal dose of Vitamin K2 supplementation in hemodialysis patients.

Clinical Trial Description

During the past few years evidence is emerging for a role of Matrix Gla Protein (MGP) as one of the most powerful inhibitors of vascular calcification (Shurgers LJ et al. Thromb Haemost 2008; 100: 593-603). MGP is a Vitamin K dependent protein. This means that he presence of Vitamin K2 is required to promote the gamma-carboxylation process turning MGP in its carboxylated and active form. Recent data show that dp-uc MGP correlates well with Vitamin K status (Cranenburg CM et al. Thrombosis and Haemostasis 2010; 104/4: 811-822).

It is widely recognized that patients with renal insufficiency treated with hemodialysis are prone to accelerated vascular calcification resulting in excess cardiovascular morbidity and mortality (Goodman WG et al. N Engl J Med 2000; 342: 1478-1483).

Consequently, the administration of Vitamin K2 supplements may protect hemodialysis patients against accelerated vascular calcification by enhancing the gamma-carboxylation process of MGP. However, the optimal dose of Vitamin K2 required to achieve these results remains to be defined ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Calcinosis
• Vascular Calcification

• NCT number: NCT01675206
• Study type: Interventional
• Source: Onze Lieve Vrouw Hospital
• Status: Completed
• Phase: Phase 3
• Start date: May 2011
• Completion date: April 2012