Evaluation of Factors II, VII, IX, X, and Proteins C and S, Following High-dose Vitamin K Supplementation

Study Overview
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Brief Summary
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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
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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). 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. 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. Have each individual consume 20 mg of Vitamin K2 orally per day for two weeks. 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. Total length of study is 4 weeks. Analyze the data sets for changes in levels / activities due to Vitamin K supplementation.

Official Title
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Evaluation of Factors II, VII, IX, X, and Proteins C and S, Following High-dose Vitamin K Supplementation

Conditions
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Thrombosis

Intervention / Treatment
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* Dietary Supplement: Vitamin K, 20mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adult male Exclusion Criteria: prior history of arterial or venous thrombosis

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: All study participants<br>Three blood collections, one at baseline, one two weeks later, and the final blood collection 4 weeks from baseline, after taking Vitamin K orally for 14 days. | Dietary Supplement: Vitamin K, 20mg<br>* Subjects will take 20mg vitamin K by mouth in capsule form everyday for 14 continuous days.<br>* Other names: Carlson Vitamin K2 Menatetrenone, in 5mg capsules;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in levels and activities due to vitamin K supplementation | 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 | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin K, Thrombosis