Safety Study of Vitamin K2 During Anticoagulation in Human Volunteers

This study has been completed.
Sponsor:
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00512928
First received: August 7, 2007
Last updated: March 25, 2008
Last verified: March 2008
  Purpose

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 Intervention
Healthy
Drug: acenocoumarol
Dietary Supplement: menaquinone-7

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety Study of Vitamin K2 During Anticoagulation in Human Volunteers

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • changes in level anticoagulation [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • changes in carboxylation level of osteocalcin and matrix-gla protein [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: September 2007
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
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
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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00512928

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

No publications provided

Responsible Party: Dr. C. Vermeer, VitaK BV
ClinicalTrials.gov Identifier: NCT00512928     History of Changes
Other Study ID Numbers: MEC 07-3-032
Study First Received: August 7, 2007
Last Updated: March 25, 2008
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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
Pharmacologic Actions
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Anticoagulants

ClinicalTrials.gov processed this record on October 19, 2014