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Vascular calcification (VC) is a predictor of cardiovascular morbidity and mortality. Hemodialysis (HD) patients suffer from severe vascular calcifications. Matrix Gla protein (MGP) is a central calcification inhibitor of the arterial wall and its activity depends on vitamin K-dependent γ-glutamate carboxylation. Noncarboxylated MGP, formed as a result of vitamin K deficiency, is associated with cardiovascular disease. Recent studies pointed towards poor vitamin K status in HD patients. We therefore aim to investigate whether daily vitamin K2 (MK-7) supplementation improves the bioactivity of vitamin K-dependent proteins in HD patients as assessed by circulating dephospho-noncarboxylated MGP (dp-ucMGP), noncarboxylated osteocalcin (ucOC) and noncarboxylated prothrombin (ucFII; PIVKA-II).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 45 µg MK-7 | Experimental | 45 µg MK-7 daily over 6 weeks |
|
| 135 µg MK-7 | Experimental | 135 µg MK-7 daily over 6 weeks |
|
| 360 µg MK-7 | Experimental | 360 µg MK-7 daily over 6 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| daily supplementation of MK-7 over 6 weeks | Dietary Supplement | once daily intake of MK-7 prior to dialysis over 6 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of plasma levels of noncarboxylated MGP | Noncarboxylated MGP levels [pmol/L] will be determined from plasma samples by a non-commercial ELISA. Plasma samples will be obtained each week of the six-week treatment period and compared to baseline values. | after 6 weeks of supplementation |
| Reduction of plasma levels of noncarboxylated osteocalcin | Noncarboxylated osteocalcin levels [ng/ml] will be determined from plasma samples by a commercial ELISA. Plasma samples will be obtained each week of the six-week treatment period and compared to baseline values. | after 6 weeks of supplementation |
| Reduction of plasma levels of inactive prothrombin (PIVKA-II) | PIVKA-II levels [ng/ml] will be determined from plasma samples by a commercial ELISA. Plasma levels at the end of the six-week treatment period will be compared to baseline levels. | after 6 weeks of supplementation |
| Measure | Description | Time Frame |
|---|---|---|
| increase of plasma levels of carboxylated MGP | Carboxylated MGP levels [pmol/L] will be determined from plasma samples by a non-commercial ELISA. Plasma samples will be obtained each week of the six-week treatment period and compared to baseline values. | after 6 weeks of supplementation |
| increase of plasma levels of carboxylated osteocalcin |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ralf Westenfeld, MD | University Clinic of the RWTH Aachen | Principal Investigator |
| Georg Schlieper, MD | University Clinic of the RWTH Aachen | Study Chair |
| Stefan Holzmann, MD | Dialysis Unit Erkelenz, Germany | Study Chair |
| Stephan Heidenreich, MD | KfH Dialysis Centre Aachen, Schurzelter Strasse | Study Chair |
| Juergen Floege, MD | University Clinic of the RWTH Aachen | Study Director |
| Thilo Krueger, MD | University Hospital of the RWTH Aachen | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KfH Dialysis Unit Aachen | Aachen | North Rhine-Westphalia | 52074 | Germany | ||
| University Hospital of the RWTH Aachen |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22169620 | Derived | Westenfeld R, Krueger T, Schlieper G, Cranenburg EC, Magdeleyns EJ, Heidenreich S, Holzmann S, Vermeer C, Jahnen-Dechent W, Ketteler M, Floege J, Schurgers LJ. Effect of vitamin K2 supplementation on functional vitamin K deficiency in hemodialysis patients: a randomized trial. Am J Kidney Dis. 2012 Feb;59(2):186-95. doi: 10.1053/j.ajkd.2011.10.041. Epub 2011 Dec 9. |
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Carboxylated MGP levels [ng/ml] will be determined from plasma samples by a commercial ELISA. Plasma samples will be obtained each week of the six-week treatment period and compared to baseline values. |
| after 6 weeks of supplementation |
| Aachen |
| North Rhine-Westphalia |
| 52074 |
| Germany |
| Dialysis Unit Erkelenz | Erkelenz | North Rhine-Westphalia | 41812 | Germany |
| 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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