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

Phase 3

Completed

• Conditions: Vascular Calcification

• Registration Number: NCT01675206
• Lead Sponsor: Rogier Caluwe

Brief Summary

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

Detailed 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 Timeline

• Study Start: 2011-05
• Primary Completion: 2011-09
• Study Completion: 2012-04
• Status Verified: 2012-08
• Study First Submitted: 2012-08-22
• Study First Submitted QC: 2012-08-25
• Last Update Submitted: 2012-08-25
• Study First Posted: 2012-08-29
• Last Update Posted: 2012-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 165

Inclusion Criteria

• age ≥18 year
• signed informed consent
• end stage renal disease treated with chronic hemodialysis at least three times a week

Exclusion Criteria

• coumarin treatment
• known intestinal malabsorption
• inability to take oral medication
• medical conditions with a considerable probability for death within 2 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
percentage of reduction in dp-ucMGP after 8 weeks of Vitamin K2 supplementation	8 weeks	this study aims at verifying whether higher doses of Vitamin K2 supplementation result in an increased reduction in dp-ucMGP

Secondary Outcome Measures

Name	Time	Method
Assessment of adverse reactions associated with Vitamin K2 intake	8 weeks