Clinical trial NCT00512928: Safety Study of Vitamin K2 During Anticoagulation in Human Volunteers
Official title: Safety Study of Vitamin K2 During Anticoagulation in Human Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: vitamin K2
oral anticoagulation
interference
level of anticoagulation
carboxylation level of osteocalcin and matrix-gla protein
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2007-08-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: changes in level anticoagulation
timeFrame: 10 weeks
Secondary outcomes:
measure: changes in carboxylation level of osteocalcin and matrix-gla protein
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University
Study officials:
affiliation: Maastricht University
name: Cees Vermeer, PhD
role: PRINCIPAL_INVESTIGATOR
References: