ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety Study of Vitamin K2 During Anticoagulation in Human Volunteers

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: NCT00512928
Recruitment Status : Completed
First Posted : August 8, 2007
Last Update Posted : March 26, 2008
Sponsor:
Information provided by:
Maastricht University Medical Center

Brief Summary:
Oral anticoagulants that are widely used for the treatment of thrombo-embolic disease exert their effect by blocking the recycling of vitamin K. Vitamin K acts as a co-factor in the posttranslational carboxylation of vitamin K-dependent proteins such as osteocalcin and matrix-gla protein. It is important to quantify the dose-response relationship of the interaction between vitamin K and oral anticoagulants and to investigate at what dosage vitamin K will interfere with oral anticoagulants in a clinically relevant way.

Condition or disease Intervention/treatment Phase
Healthy Drug: acenocoumarol Dietary Supplement: menaquinone-7 Not Applicable

Detailed Description:
From all K-vitamins, menaquinone-7 has been identified as the most effective cofactor for the carboxylation reaction of Gla-proteins. In this respect it is important to quantify the dose-response relationship of the interaction between oral anticoagulants and menaquinone-7. The primary objective of the study is to demonstrate at what menaquinone-7 intake the vitamin will interfere with oral anticoagulants in a clinically relevant way. Clinically relevant is defined as a decrease in level of anticoagulation that would require a change in oral anticoagulant treatment in order to stay within target levels. Secondary objective of the study is to investigate changes in carboxylation level of osteocalcin and matrix-gla protein after menaquinone-7 supplementation during the oral anticoagulation treatment period. This will demonstrate whether during oral anticoagulation menaquinone-7 will be transported preferentially to the liver or to other target tissues.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety Study of Vitamin K2 During Anticoagulation in Human Volunteers
Study Start Date : September 2007
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin K
Drug Information available for: Menadione
U.S. FDA Resources


Intervention Details:
    Drug: acenocoumarol
    max 5 mg per day during 10 weeks
    Other Name: sintrom mitis
    Dietary Supplement: menaquinone-7
    In successive weeks (6 weeks) the dosage is increased over the range 10 µg to 20 µg increasing to 45 µg MK-7 for the final week.
    Other Name: MenaQ7


Primary Outcome Measures :
  1. changes in level anticoagulation [ Time Frame: 10 weeks ]

Secondary Outcome Measures :
  1. changes in carboxylation level of osteocalcin and matrix-gla protein [ Time Frame: 10 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.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male and female adults between 18 and 45 years of age.
  • Subjects of normal body weight and height according to BMI < 30
  • Subject has given written consent to take part in the study

Exclusion Criteria:

  • Subjects with (a history of) of coagulation disorders
  • Subjects with (a history of) metabolic or gastrointestinal disease
  • Subjects using (multi)-vitamin supplements containing vitamin K
  • Subjects presenting chronic inflammatory diseases
  • Subjects using any medication 3 months prior to the study (e.g. corticoϊd treatment, oral anticoagulants)
  • Subjects using oral anticonception
  • Subject with (a history of) soy allergy

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): NCT00512928


Locations
Netherlands
Maastricht University
Maastricht, Netherlands, 6200 MD
Sponsors and Collaborators
Maastricht University
Investigators
Principal Investigator: Cees Vermeer, PhD Maastricht University

Responsible Party: Dr. C. Vermeer, VitaK BV
ClinicalTrials.gov Identifier: NCT00512928     History of Changes
Other Study ID Numbers: MEC 07-3-032
First Posted: August 8, 2007    Key Record Dates
Last Update Posted: March 26, 2008
Last Verified: March 2008

Keywords provided by Maastricht University Medical Center:
vitamin K2
oral anticoagulation
interference
level of anticoagulation
carboxylation level of osteocalcin and matrix-gla protein

Additional relevant MeSH terms:
Vitamins
Vitamin K
Vitamin K 2
Vitamin MK 7
Acenocoumarol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants
Anticoagulants