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

Last updated: August 1, 2011
Sponsor: RWTH Aachen University
Overall Status: Completed

Phase

3

Condition

Hyperparathyroidism

Scleroderma

Treatment

N/A

Clinical Study ID

NCT01407601
EK 111/07
  • Ages > 18
  • All Genders

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • > 18 years of age

  • minimum of 3 months of hemodialysis

  • written consent

Exclusion

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

Study Design

Total Participants: 53
Study Start date:
January 01, 2008
Estimated Completion Date:
July 31, 2009

Connect with a study center

  • KfH Dialysis Unit Aachen

    Aachen, NRW 52074
    Germany

    Site Not Available

  • University Hospital of the RWTH Aachen

    Aachen, NRW 52074
    Germany

    Site Not Available

  • Dialysis Unit Erkelenz

    Erkelenz, NRW 41812
    Germany

    Site Not Available

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