Evaluation of Factors II, VII, IX, X, and Proteins C and S, Following High-dose Vitamin K Supplementation
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|ClinicalTrials.gov Identifier: NCT01143831|
Recruitment Status : Completed
First Posted : June 14, 2010
Last Update Posted : June 12, 2012
|Condition or disease||Intervention/treatment||Phase|
|Thrombosis||Dietary Supplement: Vitamin K, 20mg||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Evaluation of Factors II, VII, IX, X, and Proteins C and S, Following High-dose Vitamin K Supplementation|
|Study Start Date :||November 2009|
|Actual Primary Completion Date :||March 2012|
|Actual Study Completion Date :||March 2012|
Experimental: All study participants
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
Subjects will take 20mg vitamin K by mouth in capsule form everyday for 14 continuous days.
Other Name: Carlson Vitamin K2 Menatetrenone, in 5mg capsules
- Change in levels and activities due to vitamin K supplementation [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01143831
|United States, North Carolina|
|University of North Carolina at Chapel Hill|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||Stephan Moll, MD||UNC Chapel Hill Department of Medicine, Division of Hematology|