NCT01675206

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
165

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started May 2011

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 29, 2012

Completed
Last Updated

August 29, 2012

Status Verified

August 1, 2012

Enrollment Period

4 months

First QC Date

August 22, 2012

Last Update Submit

August 25, 2012

Conditions

Vascular Calcification

Keywords

Vascular calcificationHemodialysisMatrix Gla ProteinVitamin K2

Outcome Measures

Primary Outcomes (1)

  • percentage of reduction in dp-ucMGP after 8 weeks of Vitamin K2 supplementation

    this study aims at verifying whether higher doses of Vitamin K2 supplementation result in an increased reduction in dp-ucMGP

    8 weeks

Secondary Outcomes (1)

  • Assessment of adverse reactions associated with Vitamin K2 intake

    8 weeks

Study Arms (3)

360 µg Vit K2

ACTIVE COMPARATOR

Administration of 360 µg of Vitamin K2 thrice weekly

Dietary Supplement: Vitamin K2 supplementation

720 µg Vit K2

ACTIVE COMPARATOR

Administration of 720 µg of Vitamin K2 thrice weekly

Dietary Supplement: Vitamin K2 supplementation

1080 µg Vit K2

ACTIVE COMPARATOR

Administration of 1080 µg of Vitamin K2 thrice weekly

Dietary Supplement: Vitamin K2 supplementation

Interventions

Vitamin K2 supplementationDIETARY_SUPPLEMENT
1080 µg Vit K2360 µg Vit K2720 µg Vit K2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Vascular Calcification

Condition Hierarchy (Ancestors)

CalcinosisCalcium Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Rogier Caluwé, MD

    OLV Hospital Aalst Belgium

    PRINCIPAL INVESTIGATOR

  • 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 CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 22, 2012

First Posted

August 29, 2012

Study Start

May 1, 2011

Primary Completion

September 1, 2011

Study Completion

April 1, 2012

Last Updated

August 29, 2012

Record last verified: 2012-08