Safety Study of Vitamin K2 During Anticoagulation in Human Volunteers

NCT00512928 | Completed

• 1 other identifier: MEC 07-3-032
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• changes in level anticoagulation

  10 weeks

Secondary Outcomes (1)

• changes in carboxylation level of osteocalcin and matrix-gla protein

  10 weeks

Interventions

acenocoumarol DRUG

max 5 mg per day during 10 weeks

Also known as: sintrom mitis

menaquinone-7 DIETARY_SUPPLEMENT

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.

Also known as: MenaQ7

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University: lead

Study Sites (1)

Maastricht University

Maastricht, 6200 MD, Netherlands

Location

MeSH Terms

Interventions

Acenocoumarol; menaquinone 7

Intervention Hierarchy (Ancestors)

4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Cees Vermeer, PhD

  Maastricht University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 7, 2007
• First Posted: August 8, 2007
• Study Start: September 1, 2007
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: March 26, 2008

Record last verified: 2008-03

Locations

NL (1)