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

RWTH Aachen University53 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

CKD 5D, Hemodialysis

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

KfH Dialysis Unit Aachen

Aachen, North Rhine-Westphalia, Germany

University Hospital of the RWTH Aachen

Aachen, North Rhine-Westphalia, Germany

Dialysis Unit Erkelenz

Erkelenz, North Rhine-Westphalia, Germany

Outcomes

Primary Outcomes

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.