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

RWTH Aachen University

Status and phase: Completed; Phase 3

Conditions: CKD 5D, Hemodialysis

Treatments: Dietary Supplement: daily supplementation of MK-7 over 6 weeks

Study type: Interventional

Funder types: Other

Identifiers

NCT01407601

EK 111/07

Details and patient eligibility

About

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).

Enrollment: 53 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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53 participants in 3 patient groups

45 µg MK-7

Experimental group

Description:

45 µg MK-7 daily over 6 weeks

Treatment:

Dietary Supplement: daily supplementation of MK-7 over 6 weeks

135 µg MK-7

Experimental group

Description:

135 µg MK-7 daily over 6 weeks

Treatment:

Dietary Supplement: daily supplementation of MK-7 over 6 weeks

360 µg MK-7

Experimental group

Description:

360 µg MK-7 daily over 6 weeks

Treatment:

Dietary Supplement: daily supplementation of MK-7 over 6 weeks