Safety Study of Vitamin K2 During Anticoagulation in Human Volunteers

Healthy Clinical Trial

Official title:

Safety Study of Vitamin K2 During Anticoagulation in Human Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00512928
• Other study ID #: MEC 07-3-032
• Status: Completed
• Phase: N/A
• First received: August 7, 2007
• Last updated: March 25, 2008
• Start date: September 2007
• Est. completion date: December 2007

Study information

• Verified date: March 2008
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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. cortico?d treatment, oral anticoagulants)

• Subjects using oral anticonception

• Subject with (a history of) soy allergy

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• acenocoumarol
max 5 mg per day during 10 weeks

Dietary Supplement:
• 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.

Locations

Country	Name	City	State
Netherlands	Maastricht University	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in level anticoagulation		10 weeks	No
Secondary	changes in carboxylation level of osteocalcin and matrix-gla protein		10 weeks	No