Dose Defining Study for the Administration of Vitamin K2 Supplements in Hemodialysis Patients

August 25, 2012 updated by: Rogier Caluwe

Randomized Prospective Open Interventional Multi-centre Study on Finding the Optimal Dose of Vitamin K2 Supplements for Hemodialysis Patients

This study aims at finding the optimal dose of Vitamin K2 supplementation in hemodialysis patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

During the past few years evidence is emerging for a role of Matrix Gla Protein (MGP) as one of the most powerful inhibitors of vascular calcification (Shurgers LJ et al. Thromb Haemost 2008; 100: 593-603). MGP is a Vitamin K dependent protein. This means that he presence of Vitamin K2 is required to promote the gamma-carboxylation process turning MGP in its carboxylated and active form. Recent data show that dp-uc MGP correlates well with Vitamin K status (Cranenburg CM et al. Thrombosis and Haemostasis 2010; 104/4: 811-822).

It is widely recognized that patients with renal insufficiency treated with hemodialysis are prone to accelerated vascular calcification resulting in excess cardiovascular morbidity and mortality (Goodman WG et al. N Engl J Med 2000; 342: 1478-1483).

Consequently, the administration of Vitamin K2 supplements may protect hemodialysis patients against accelerated vascular calcification by enhancing the gamma-carboxylation process of MGP. However, the optimal dose of Vitamin K2 required to achieve these results remains to be defined

Study Type

Interventional

Enrollment (Actual)

165

Phase

  • Phase 3

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age ≥18 year
  • signed informed consent
  • end stage renal disease treated with chronic hemodialysis at least three times a week

Exclusion Criteria:

  • coumarin treatment
  • known intestinal malabsorption
  • inability to take oral medication
  • medical conditions with a considerable probability for death within 2 months

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 360 µg Vit K2
Administration of 360 µg of Vitamin K2 thrice weekly
Dietary supplement: Vitamin K2 supplementation
Active Comparator: 720 µg Vit K2
Administration of 720 µg of Vitamin K2 thrice weekly
Dietary supplement: Vitamin K2 supplementation
Active Comparator: 1080 µg Vit K2
Administration of 1080 µg of Vitamin K2 thrice weekly
Dietary supplement: Vitamin K2 supplementation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
percentage of reduction in dp-ucMGP after 8 weeks of Vitamin K2 supplementation
Time Frame: 8 weeks
this study aims at verifying whether higher doses of Vitamin K2 supplementation result in an increased reduction in dp-ucMGP
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Assessment of adverse reactions associated with Vitamin K2 intake
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

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

Sponsor

Rogier Caluwe

Investigators

  • Principal Investigator: Rogier Caluwé, MD, OLV Hospital Aalst Belgium
  • Study Chair: Bruno Van Vlem, MD, PhD, OLV Hospital Aalst Belgium
  • Study Chair: An Devriese, MD, PhD, AZ St.-Jan Brugge Belgium
  • Study Chair: Stefaan Vandecasteele, MD, PhD, AZ St.-Jan Brugge Belgium

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

May 1, 2011

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

August 22, 2012

First Submitted That Met QC Criteria

August 25, 2012

First Posted (Estimate)

August 29, 2012

Study Record Updates

Last Update Posted (Estimate)

August 29, 2012

Last Update Submitted That Met QC Criteria

August 25, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010/066

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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