Safety Study of Vitamin K2 During Anticoagulation in Human Volunteers
This study has been completed.
Information provided by:
Maastricht University Medical Center
First received: August 7, 2007
Last updated: March 25, 2008
Last verified: March 2008
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.
Dietary Supplement: menaquinone-7
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Safety Study of Vitamin K2 During Anticoagulation in Human Volunteers
Primary Outcome Measures:
- changes in level anticoagulation [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- changes in carboxylation level of osteocalcin and matrix-gla protein [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||December 2007 (Final data collection date for primary outcome measure)
max 5 mg per day during 10 weeks
Other Name: sintrom mitis
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.
Other Name: MenaQ7
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.
|Ages Eligible for Study:
||18 Years to 45 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00512928
|Maastricht, Netherlands, 6200 MD |
||Cees Vermeer, PhD
No publications provided
||Dr. C. Vermeer, VitaK BV
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 7, 2007
||March 25, 2008
||Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Keywords provided by Maastricht University Medical Center:
level of anticoagulation
carboxylation level of osteocalcin and matrix-gla protein
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 26, 2015
Vitamin K 2
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs