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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2009-07-31

Brief Summary

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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).

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Detailed Description

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Conditions

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CKD 5D, Hemodialysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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45 µg MK-7

45 µg MK-7 daily over 6 weeks

Group Type EXPERIMENTAL

daily supplementation of MK-7 over 6 weeks

Intervention Type DIETARY_SUPPLEMENT

once daily intake of MK-7 prior to dialysis over 6 weeks

135 µg MK-7

135 µg MK-7 daily over 6 weeks

Group Type EXPERIMENTAL

daily supplementation of MK-7 over 6 weeks

Intervention Type DIETARY_SUPPLEMENT

once daily intake of MK-7 prior to dialysis over 6 weeks

360 µg MK-7

360 µg MK-7 daily over 6 weeks

Group Type EXPERIMENTAL

daily supplementation of MK-7 over 6 weeks

Intervention Type DIETARY_SUPPLEMENT

once daily intake of MK-7 prior to dialysis over 6 weeks

Interventions

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daily supplementation of MK-7 over 6 weeks

once daily intake of MK-7 prior to dialysis over 6 weeks

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No