Thrombosis Clinical Trial
Official title:
Evaluation of Factors II, VII, IX, X, and Proteins C and S, Following High-dose Vitamin K Supplementation
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.
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.
;
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
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