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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

Tracking Information
First Submitted Date  ICMJE July 29, 2011
First Posted Date  ICMJE August 2, 2011
Last Update Posted Date August 2, 2011
Study Start Date  ICMJE January 2008
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 1, 2011)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 1, 2011)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vitamin K2 Supplementation to Activate Matrix Gla Protein (MGP) as Endogenous Inhibitor of Vascular Calcification in Hemodialysis Patients
Official Title  ICMJE Food Supplementation With Vitamin K2 to Activate MGP as an Endogenous Inhibitor of Vascular Calcification in Hemodialysis Patients
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE CKD 5D, Hemodialysis
Intervention  ICMJE Dietary Supplement: daily supplementation of MK-7 over 6 weeks
once daily intake of MK-7 prior to dialysis over 6 weeks
Study Arms  ICMJE
  • Experimental: 45 µg MK-7
    45 µg MK-7 daily over 6 weeks
    Intervention: Dietary Supplement: daily supplementation of MK-7 over 6 weeks
  • Experimental: 135 µg MK-7
    135 µg MK-7 daily over 6 weeks
    Intervention: Dietary Supplement: daily supplementation of MK-7 over 6 weeks
  • Experimental: 360 µg MK-7
    360 µg MK-7 daily over 6 weeks
    Intervention: Dietary Supplement: daily supplementation of MK-7 over 6 weeks
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 1, 2011)
53
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2009
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01407601
Other Study ID Numbers  ICMJE EK 111/07
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party CTC Aachen, University Hospital of the RWTH Aachen
Study Sponsor  ICMJE RWTH Aachen University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account RWTH Aachen University
Verification Date August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP