Vitamin K2 Supplementation to Activate Matrix Gla Protein (MGP) as Endogenous Inhibitor of Vascular Calcification in Hemodialysis Patients
- Conditions
- CKD 5D, Hemodialysis
- Interventions
- Dietary Supplement: daily supplementation of MK-7 over 6 weeks
- Registration Number
- NCT01407601
- Lead Sponsor
- RWTH Aachen University
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 53
- > 18 years of age
- minimum of 3 months of hemodialysis
- written consent
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 45 µg MK-7 daily supplementation of MK-7 over 6 weeks 45 µg MK-7 daily over 6 weeks 135 µg MK-7 daily supplementation of MK-7 over 6 weeks 135 µg MK-7 daily over 6 weeks 360 µg MK-7 daily supplementation of MK-7 over 6 weeks 360 µg MK-7 daily over 6 weeks
- Primary Outcome Measures
Name Time Method Reduction of plasma levels of noncarboxylated MGP 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 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) 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
Name Time Method increase of plasma levels of carboxylated MGP 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 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.
Trial Locations
- Locations (3)
University Hospital of the RWTH Aachen
🇩🇪Aachen, NRW, Germany
KfH Dialysis Unit Aachen
🇩🇪Aachen, NRW, Germany
Dialysis Unit Erkelenz
🇩🇪Erkelenz, NRW, Germany