Safety Study of Vitamin K2 During Anticoagulation in Human Volunteers

Not Applicable

Completed

• Conditions: Healthy

• Registration Number: NCT00512928
• Lead Sponsor: Maastricht University

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.

Study Timeline

• Study First Submitted: 2007-08-07
• Study First Submitted QC: 2007-08-07
• Study First Posted: 2007-08-08
• Study Start: 2007-09
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Status Verified: 2008-03
• Last Update Submitted: 2008-03-25
• Last Update Posted: 2008-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
changes in level anticoagulation	10 weeks

Secondary Outcome Measures

Name	Time	Method
changes in carboxylation level of osteocalcin and matrix-gla protein	10 weeks

Trial Locations

Locations (1)

Maastricht University; 🇳🇱 Maastricht, Netherlands