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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
Sponsor:
Information provided by:
RWTH Aachen University

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
CKD 5D, Hemodialysis Dietary Supplement: daily supplementation of MK-7 over 6 weeks Phase 3

Study Design
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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

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U.S. FDA Resources

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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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


Locations
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
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
First Posted: August 2, 2011    Key Record Dates
Last Update Posted: August 2, 2011
Last Verified: August 2011

Keywords provided by RWTH Aachen University:
vitamin K
MK-7
Hemodialysis
 vascular calcification
Matrix Gla protein
Osteocalcin

Additional relevant MeSH terms:
Calcinosis
Vascular Calcification
Calcium Metabolism Disorders
Metabolic Diseases
Vitamins
Vitamin K
Vitamin K 2
Vitamin MK 7
 Micronutrients
Growth Substances
Physiological Effects of Drugs
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants