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

August 7, 2007
March 25, 2008
September 2007
December 2007   (final data collection date for primary outcome measure)
changes in level anticoagulation [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
changes in level anticoagulation [ Time Frame: 10 weeks ]
Complete list of historical versions of study NCT00512928 on ClinicalTrials.gov Archive Site
changes in carboxylation level of osteocalcin and matrix-gla protein [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
changes in carboxylation level of osteocalcin and matrix-gla protein [ Time Frame: 10 weeks ]
Not Provided
Not Provided
 
Safety Study of Vitamin K2 During Anticoagulation in Human Volunteers
Safety Study of Vitamin K2 During Anticoagulation in Human Volunteers

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.

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.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy
  • 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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
December 2007
December 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00512928
MEC 07-3-032
No
Dr. C. Vermeer, VitaK BV
Maastricht University
Not Provided
Principal Investigator: Cees Vermeer, PhD Maastricht University
Maastricht University Medical Center
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP