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

Phase 3

Completed

• Conditions: Vascular Calcification
• Interventions: Dietary Supplement: Vitamin K2 supplementation

• 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

Arm && Interventions

Group	Intervention	Description
360 µg Vit K2	Vitamin K2 supplementation	Administration of 360 µg of Vitamin K2 thrice weekly
720 µg Vit K2	Vitamin K2 supplementation	Administration of 720 µg of Vitamin K2 thrice weekly
1080 µg Vit K2	Vitamin K2 supplementation	Administration of 1080 µg of Vitamin K2 thrice weekly

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