Thrombosis
Conditions
Keywords
Vitamin K, Thrombosis
Brief summary
The purpose of this study is to evaluate factor levels of the pro coagulant factors II, VII, IX, X, and the anticoagulant factors protein C and S in healthy volunteers during the intake of elevated levels of vitamin K in order to investigate whether there is any evidence that high dose vitamin K intake increases plasma coagulation factor activity.
Detailed description
1. Recruit 8 male healthy individuals with no prior history of arterial or venous thrombosis (2 each from each of the following age ranges: 20-34, 35-49, 50-64, \>65). 2. Visit 1: Measure baseline activity levels of Factor II, Factor VII, Factor IX, Factor X, and levels of D-Dimer, TAT complexes, protein C and S activities. Also measure thrombin generation potential. Collaboration with a research laboratory will be sought to also determine factor VIIa levels. 3. Visit 2: Measure activity of Factor II, Factor VII, Factor IX, Factor X, levels of D-Dimer, TAT complexes, protein C and S activities and thrombin generation potential at the end of the 2 week period. 4. Have each individual consume 20 mg of Vitamin K2 orally per day for two weeks. 5. Visit 3: Measure Factor II, Factor VII, Factor IX, Factor X, D-Dimer, TAT complexes, protein C and S activities and thrombin generation potential at the end of the 2 week period. 6. Total length of study is 4 weeks. 7. Analyze the data sets for changes in levels / activities due to Vitamin K supplementation.
Interventions
Subjects will take 20mg vitamin K by mouth in capsule form everyday for 14 continuous days.
Sponsors
Study design
Eligibility
Inclusion criteria
* Healthy adult male
Exclusion criteria
* prior history of arterial or venous thrombosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in levels and activities due to vitamin K supplementation | 4 weeks | Levels and activities to be recorded at three time points: Factor II, Factor VII, Factor IX, Factor X, D-dimer, TAT complexes, Protein C and S, thrombin generation potential |
Countries
United States