Safety Study of Vitamin K2 During Anticoagulation in Human Volunteers

NCT ID: NCT00512928

Last Updated: 2008-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2007-12-31

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.

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

acenocoumarol

max 5 mg per day during 10 weeks

Intervention Type: DRUG

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.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

sintrom mitis; 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Maastricht University

OTHER

Sponsor Role: lead

Responsible Party

VitaK BV

Principal Investigators

Cees Vermeer, PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University

Locations

Maastricht University

Maastricht, , Netherlands

Countries

Netherlands

Other Identifiers

MEC 07-3-032

Identifier Type: -

Identifier Source: org_study_id