Safety Study of Vitamin K2 During Anticoagulation in Human Volunteers

Safety Study of Vitamin K2 During Anticoagulation in Human Volunteers

Sponsors

Lead Sponsor: Maastricht University

Source 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.

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.

Overall Status Completed
Start Date 2007-09-01
Completion Date 2007-12-01
Primary Completion Date 2007-12-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
changes in level anticoagulation 10 weeks
Secondary Outcome
Measure Time Frame
changes in carboxylation level of osteocalcin and matrix-gla protein 10 weeks
Enrollment 20
Condition
Intervention

Intervention Type: Drug

Intervention Name: acenocoumarol

Description: max 5 mg per day during 10 weeks

Other Name: sintrom mitis

Intervention Type: Dietary Supplement

Intervention Name: menaquinone-7

Description: 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

Eligibility

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 45 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Cees Vermeer, PhD Principal Investigator Maastricht University
Location
Facility: Maastricht University
Location Countries

Netherlands

Verification Date

2008-03-01

Responsible Party

Name Title: Dr. C. Vermeer

Organization: VitaK BV

Keywords
Has Expanded Access No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov

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