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Safety Study of Vitamin K2 During Anticoagulation in Human Volunteers

NCT ID: NCT00512928

Last Updated: 2008-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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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

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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

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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

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Healthy

Keywords

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vitamin K2 oral anticoagulation interference level of anticoagulation carboxylation level of osteocalcin and matrix-gla protein

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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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

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sintrom mitis MenaQ7

Eligibility Criteria

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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

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Maastricht University

OTHER

Sponsor Role lead

Responsible Party

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VitaK BV

Principal Investigators

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Cees Vermeer, PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht University

Locations

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Maastricht University

Maastricht, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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MEC 07-3-032

Identifier Type: -

Identifier Source: org_study_id