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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01675206
• Other study ID #: 2010/066
• Status: Completed
• Phase: Phase 3
• First received: August 22, 2012
• Last updated: August 25, 2012
• Start date: May 2011
• Est. completion date: April 2012

Study information

• Verified date: August 2012
• Source: Onze Lieve Vrouw Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: April 2012
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Intervention

Dietary Supplement:
• Vitamin K2 supplementation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rogier Caluwe

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage of reduction in dp-ucMGP after 8 weeks of Vitamin K2 supplementation	this study aims at verifying whether higher doses of Vitamin K2 supplementation result in an increased reduction in dp-ucMGP	8 weeks	No
Secondary	Assessment of adverse reactions associated with Vitamin K2 intake		8 weeks	Yes