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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01675206

Enrollment

165

Registered

2012-08-29

Start date

2011-05-31

Completion date

2012-04-30

Last updated

2012-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vascular Calcification

Keywords

Vascular calcification, Hemodialysis, Matrix Gla Protein, Vitamin K2

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

Interventions

DIETARY_SUPPLEMENTVitamin K2 supplementation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame
Assessment of adverse reactions associated with Vitamin K2 intake	8 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026