Vitamin K2 Supplementation to Activate Matrix Gla Protein (MGP) as Endogenous Inhibitor of Vascular Calcification in Hemodialysis Patients
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ClinicalTrials.gov Identifier: NCT01407601 |
Recruitment Status :
Completed
First Posted : August 2, 2011
Last Update Posted : August 2, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
CKD 5D, Hemodialysis | Dietary Supplement: daily supplementation of MK-7 over 6 weeks | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 53 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Basic Science |
Official Title: | Food Supplementation With Vitamin K2 to Activate MGP as an Endogenous Inhibitor of Vascular Calcification in Hemodialysis Patients |
Study Start Date : | January 2008 |
Actual Primary Completion Date : | May 2008 |
Actual Study Completion Date : | July 2009 |

Arm | Intervention/treatment |
---|---|
Experimental: 45 µg MK-7
45 µg MK-7 daily over 6 weeks
|
Dietary Supplement: daily supplementation of MK-7 over 6 weeks
once daily intake of MK-7 prior to dialysis over 6 weeks |
Experimental: 135 µg MK-7
135 µg MK-7 daily over 6 weeks
|
Dietary Supplement: daily supplementation of MK-7 over 6 weeks
once daily intake of MK-7 prior to dialysis over 6 weeks |
Experimental: 360 µg MK-7
360 µg MK-7 daily over 6 weeks
|
Dietary Supplement: daily supplementation of MK-7 over 6 weeks
once daily intake of MK-7 prior to dialysis over 6 weeks |
- Reduction of plasma levels of noncarboxylated MGP [ Time Frame: after 6 weeks of supplementation ]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.
- Reduction of plasma levels of noncarboxylated osteocalcin [ Time Frame: after 6 weeks of supplementation ]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.
- Reduction of plasma levels of inactive prothrombin (PIVKA-II) [ Time Frame: after 6 weeks of supplementation ]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.
- increase of plasma levels of carboxylated MGP [ Time Frame: after 6 weeks of supplementation ]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.
- increase of plasma levels of carboxylated osteocalcin [ Time Frame: after 6 weeks of supplementation ]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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- > 18 years of age
- minimum of 3 months of hemodialysis
- written consent
Exclusion Criteria:
- chronic or acute bowel disease
- soy bean allergy
- active Vitamin K Supplementation
- oral anticoagulation with vitamin K Antagonists (coumarins)
- systemic therapy using steroids
- positive history for thrombosis or embolism
- pregnancy

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01407601
Germany | |
KfH Dialysis Unit Aachen | |
Aachen, NRW, Germany, 52074 | |
University Hospital of the RWTH Aachen | |
Aachen, NRW, Germany, 52074 | |
Dialysis Unit Erkelenz | |
Erkelenz, NRW, Germany, 41812 |
Principal Investigator: | Ralf Westenfeld, MD | University Clinic of the RWTH Aachen | |
Study Chair: | 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 Director: | Juergen Floege, MD | University Clinic of the RWTH Aachen | |
Study Chair: | Thilo Krueger, MD | University Hospital of the RWTH Aachen |
Responsible Party: | CTC Aachen, University Hospital of the RWTH Aachen |
ClinicalTrials.gov Identifier: | NCT01407601 |
Other Study ID Numbers: |
EK 111/07 |
First Posted: | August 2, 2011 Key Record Dates |
Last Update Posted: | August 2, 2011 |
Last Verified: | August 2011 |
vitamin K MK-7 Hemodialysis |
vascular calcification Matrix Gla protein Osteocalcin |
Calcinosis Vascular Calcification Calcium Metabolism Disorders Metabolic Diseases |