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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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

Detailed Summary:

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


Sponsor: Rogier Caluwe

Current Primary Outcome: percentage of reduction in dp-ucMGP after 8 weeks of Vitamin K2 supplementation [ Time Frame: 8 weeks ]

this study aims at verifying whether higher doses of Vitamin K2 supplementation result in an increased reduction in dp-ucMGP


Original Primary Outcome: Same as current

Current Secondary Outcome: Assessment of adverse reactions associated with Vitamin K2 intake [ Time Frame: 8 weeks ]

Original Secondary Outcome: Same as current

Information By: Onze Lieve Vrouw Hospital

Dates:
Date Received: August 22, 2012
Date Started: May 2011
Date Completion:
Last Updated: August 25, 2012
Last Verified: August 2012