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This study aims at finding the optimal dose of Vitamin K2 supplementation in hemodialysis patients.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 360 µg Vit K2 | Active Comparator | Administration of 360 µg of Vitamin K2 thrice weekly |
|
| 720 µg Vit K2 | Active Comparator | Administration of 720 µg of Vitamin K2 thrice weekly |
|
| 1080 µg Vit K2 | Active Comparator | Administration of 1080 µg of Vitamin K2 thrice weekly |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin K2 supplementation | Dietary Supplement |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of adverse reactions associated with Vitamin K2 intake | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rogier Caluwé, MD | OLV Hospital Aalst Belgium | Principal Investigator |
| Bruno Van Vlem, MD, PhD | OLV Hospital Aalst Belgium | Study Chair |
| An Devriese, MD, PhD | AZ St.-Jan Brugge Belgium | Study Chair |
| Stefaan Vandecasteele, MD, PhD | AZ St.-Jan Brugge Belgium | Study Chair |
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| ID | Term |
|---|---|
| D061205 | Vascular Calcification |
| ID | Term |
|---|---|
| D002114 | Calcinosis |
| D002128 | Calcium Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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