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

NCT ID: NCT01675206

Last Updated: 2012-08-29

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

165 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2012-04-30

Brief Summary

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

Detailed Description

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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

Conditions

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Vascular Calcification

Keywords

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Vascular calcification Hemodialysis Matrix Gla Protein Vitamin K2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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360 µg Vit K2

Administration of 360 µg of Vitamin K2 thrice weekly

Group Type ACTIVE_COMPARATOR

Vitamin K2 supplementation

Intervention Type DIETARY_SUPPLEMENT

720 µg Vit K2

Administration of 720 µg of Vitamin K2 thrice weekly

Group Type ACTIVE_COMPARATOR

Vitamin K2 supplementation

Intervention Type DIETARY_SUPPLEMENT

1080 µg Vit K2

Administration of 1080 µg of Vitamin K2 thrice weekly

Group Type ACTIVE_COMPARATOR

Vitamin K2 supplementation

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Vitamin K2 supplementation

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rogier Caluwe

OTHER

Sponsor Role lead

Responsible Party

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Rogier Caluwe

MD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Rogier Caluwé, MD

Role: PRINCIPAL_INVESTIGATOR

OLV Hospital Aalst Belgium

Bruno Van Vlem, MD, PhD

Role: STUDY_CHAIR

OLV Hospital Aalst Belgium

An Devriese, MD, PhD

Role: STUDY_CHAIR

AZ St.-Jan Brugge Belgium

Stefaan Vandecasteele, MD, PhD

Role: STUDY_CHAIR

AZ St.-Jan Brugge Belgium

Other Identifiers

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2010/066

Identifier Type: -

Identifier Source: org_study_id