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

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

Detailed Description
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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

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

Conditions
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Vascular Calcification

Intervention / Treatment
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* Dietary Supplement: Vitamin K2 supplementation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 360 µg Vit K2<br>Administration of 360 µg of Vitamin K2 thrice weekly | Dietary Supplement: Vitamin K2 supplementation<br> <br> |
| Active Comparator: 720 µg Vit K2<br>Administration of 720 µg of Vitamin K2 thrice weekly | Dietary Supplement: Vitamin K2 supplementation<br> <br> |
| Active Comparator: 1080 µg Vit K2<br>Administration of 1080 µg of Vitamin K2 thrice weekly | Dietary Supplement: Vitamin K2 supplementation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of adverse reactions associated with Vitamin K2 intake |  | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vascular calcification, Hemodialysis, Matrix Gla Protein, Vitamin K2