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Vitamin K2 Supplementation to Activate Matrix Gla Protein (MGP) as Endogenous Inhibitor of Vascular Calcification in Hemodialysis Patients

NCT01407601 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2011-08-02

No results posted yet for this study

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).

Conditions

  • CKD 5D, Hemodialysis

Interventions

DIETARY_SUPPLEMENT

daily supplementation of MK-7 over 6 weeks

once daily intake of MK-7 prior to dialysis over 6 weeks

Sponsors & Collaborators

  • RWTH Aachen University

    lead OTHER

Principal Investigators

  • Ralf Westenfeld, MD · University Clinic of the RWTH Aachen

  • Georg Schlieper, MD · University Clinic of the RWTH Aachen

  • Stefan Holzmann, MD · Dialysis Unit Erkelenz, Germany

  • Stephan Heidenreich, MD · KfH Dialysis Centre Aachen, Schurzelter Strasse

  • Juergen Floege, MD · University Clinic of the RWTH Aachen

  • Thilo Krueger, MD · University Hospital of the RWTH Aachen

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2008-05-31
Completion
2009-07-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01407601 on ClinicalTrials.gov