CKD 5D, Hemodialysis Clinical Trial
Official title:
Food Supplementation With Vitamin K2 to Activate MGP as an Endogenous Inhibitor of Vascular Calcification in Hemodialysis Patients
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).
| Status | Completed |
| Enrollment | 53 |
| Est. completion date | July 2009 |
| Est. primary completion date | May 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
| Country | Name | City | State |
|---|---|---|---|
| Germany | KfH Dialysis Unit Aachen | Aachen | NRW |
| Germany | University Hospital of the RWTH Aachen | Aachen | NRW |
| Germany | Dialysis Unit Erkelenz | Erkelenz | NRW |
| Lead Sponsor | Collaborator |
|---|---|
| RWTH Aachen University |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Reduction of plasma levels of noncarboxylated MGP | 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. | after 6 weeks of supplementation | No |
| Primary | Reduction of plasma levels of noncarboxylated osteocalcin | 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. | after 6 weeks of supplementation | No |
| Primary | Reduction of plasma levels of inactive prothrombin (PIVKA-II) | 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. | after 6 weeks of supplementation | No |
| Secondary | increase of plasma levels of carboxylated MGP | 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. | after 6 weeks of supplementation | No |
| Secondary | increase of plasma levels of carboxylated osteocalcin | 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. | after 6 weeks of supplementation | No |