Trial | NCT01407601  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    menaquinone ...

  • Study Participants

    53
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).
Study Started
Jan 31
2008
Primary Completion
May 31
2008
Study Completion
Jul 31
2009
Last Update
Aug 02
2011
Estimate

Dietary Supplement daily supplementation of MK-7 over 6 weeks

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

45 µg MK-7 Experimental

45 µg MK-7 daily over 6 weeks

135 µg MK-7 Experimental

135 µg MK-7 daily over 6 weeks

360 µg MK-7 Experimental

360 µg MK-7 daily over 6 weeks

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
No Results Posted