CKD 5D, Hemodialysis
Conditions
Keywords
vitamin K, MK-7, Hemodialysis, vascular calcification, Matrix Gla protein, Osteocalcin
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).
Interventions
DIETARY_SUPPLEMENTdaily supplementation of MK-7 over 6 weeks
once daily intake of MK-7 prior to dialysis over 6 weeks
Sponsors
RWTH Aachen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Germany
Outcome results
None listed