Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 9 of 50 for:    vitamin k2

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01675206
Recruitment Status : Completed
First Posted : August 29, 2012
Last Update Posted : August 29, 2012
Sponsor:
Information provided by (Responsible Party):
Rogier Caluwe, Onze Lieve Vrouw Hospital

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

Condition or disease Intervention/treatment Phase
Vascular Calcification Dietary Supplement: Vitamin K2 supplementation Phase 3

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


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 165 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Randomized Prospective Open Interventional Multi-centre Study on Finding the Optimal Dose of Vitamin K2 Supplements for Hemodialysis Patients
Study Start Date : May 2011
Actual Primary Completion Date : September 2011
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis Vitamin K
Drug Information available for: Menadione

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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Assessment of adverse reactions associated with Vitamin K2 intake [ Time Frame: 8 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01675206


Sponsors and Collaborators
Rogier Caluwe
Investigators
Layout table for investigator information
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

Layout table for additonal information
Responsible Party: Rogier Caluwe, MD, Onze Lieve Vrouw Hospital
ClinicalTrials.gov Identifier: NCT01675206     History of Changes
Other Study ID Numbers: 2010/066
First Posted: August 29, 2012    Key Record Dates
Last Update Posted: August 29, 2012
Last Verified: August 2012
Keywords provided by Rogier Caluwe, Onze Lieve Vrouw Hospital:
Vascular calcification
Hemodialysis
Matrix Gla Protein
Vitamin K2
Additional relevant MeSH terms:
Layout table for MeSH terms
Vitamins
Vitamin K
Vitamin K 2
Vitamin MK 7
Calcinosis
Vascular Calcification
Calcium Metabolism Disorders
Metabolic Diseases
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants