Vitamin K2 Supplementation to Activate Matrix Gla Protein (MGP) as Endogenous Inhibitor of Vascular Calcification in Hemodialysis Patients
This study has been completed.
Sponsor:
RWTH Aachen University
Information provided by:
RWTH Aachen University
ClinicalTrials.gov Identifier:
NCT01407601
First received: July 29, 2011
Last updated: August 1, 2011
Last verified: August 2011
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
CKD 5D, Hemodialysis |
Dietary Supplement: daily supplementation of MK-7 over 6 weeks |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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 |
Resource links provided by NLM:
Further study details as provided by RWTH Aachen University:
Primary Outcome Measures:
- Reduction of plasma levels of noncarboxylated MGP [ Time Frame: after 6 weeks of supplementation ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- increase of plasma levels of carboxylated MGP [ Time Frame: after 6 weeks of supplementation ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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.
| Enrollment: | 53 |
| Study Start Date: | January 2008 |
| Study Completion Date: | July 2009 |
| Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01407601
Locations
| Germany | |
| University Hospital of the RWTH Aachen | |
| Aachen, NRW, Germany, 52074 | |
| KfH Dialysis Unit Aachen | |
| Aachen, NRW, Germany, 52074 | |
| Dialysis Unit Erkelenz | |
| Erkelenz, NRW, Germany, 41812 | |
Sponsors and Collaborators
RWTH Aachen University
Investigators
| 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 |
More Information
No publications provided by RWTH Aachen University
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | CTC Aachen, University Hospital of the RWTH Aachen |
| ClinicalTrials.gov Identifier: | NCT01407601 History of Changes |
| Other Study ID Numbers: | EK 111/07 |
| Study First Received: | July 29, 2011 |
| Last Updated: | August 1, 2011 |
| Health Authority: | Ethics Commission at the Medical Faculty; University Hospital of the RWTH Aachen: Germany |
Keywords provided by RWTH Aachen University:
|
vitamin K MK-7 Hemodialysis |
vascular calcification Matrix Gla protein Osteocalcin |
Additional relevant MeSH terms:
|
Calcinosis Calcium Metabolism Disorders Metabolic Diseases Vitamin K Vitamins Vitamin K 2 Micronutrients Growth Substances Physiological Effects of Drugs |
Pharmacologic Actions Antifibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Hemostatics Coagulants Hematologic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013