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

August 1, 2011 updated by: RWTH Aachen University

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • NRW
      • Aachen, NRW, Germany, 52074
        • KfH Dialysis Unit Aachen
      • Aachen, NRW, Germany, 52074
        • University Hospital of the RWTH Aachen
      • Erkelenz, NRW, Germany, 41812
        • Dialysis Unit Erkelenz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 45 µg MK-7
45 µg MK-7 daily over 6 weeks
Dietary supplement: daily supplementation of MK-7 over 6 weeks
once daily intake of MK-7 prior to dialysis over 6 weeks
Experimental: 135 µg MK-7
135 µg MK-7 daily over 6 weeks
Dietary supplement: daily supplementation of MK-7 over 6 weeks
once daily intake of MK-7 prior to dialysis over 6 weeks
Experimental: 360 µg MK-7
360 µg MK-7 daily over 6 weeks
Dietary supplement: daily supplementation of MK-7 over 6 weeks
once daily intake of MK-7 prior to dialysis over 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction of plasma levels of noncarboxylated MGP
Time Frame: 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.
after 6 weeks of supplementation
Reduction of plasma levels of noncarboxylated osteocalcin
Time Frame: 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.
after 6 weeks of supplementation
Reduction of plasma levels of inactive prothrombin (PIVKA-II)
Time Frame: 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.
after 6 weeks of supplementation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
increase of plasma levels of carboxylated MGP
Time Frame: 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.
after 6 weeks of supplementation
increase of plasma levels of carboxylated osteocalcin
Time Frame: 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.
after 6 weeks of supplementation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RWTH Aachen University

Investigators

  • Principal Investigator: Ralf Westenfeld, MD, University Clinic of the RWTH Aachen
  • Study Chair: Georg Schlieper, MD, University Clinic of the RWTH Aachen
  • Study Chair: Stefan Holzmann, MD, Dialysis Unit Erkelenz, Germany
  • Study Chair: Stephan Heidenreich, MD, KfH Dialysis Centre Aachen, Schurzelter Strasse
  • Study Director: Juergen Floege, MD, University Clinic of the RWTH Aachen
  • Study Chair: Thilo Krueger, MD, University Hospital of the RWTH Aachen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

July 29, 2011

First Submitted That Met QC Criteria

August 1, 2011

First Posted (Estimate)

August 2, 2011

Study Record Updates

Last Update Posted (Estimate)

August 2, 2011

Last Update Submitted That Met QC Criteria

August 1, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EK 111/07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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