NCT01143831

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Stephan Moll, MD · Academic / Other
• Sex: Male
• Age: 20 Years – 85 Years
• Healthy volunteers: Accepted

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.

Conditions

• Thrombosis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Vitamin K, 20mg	Subjects will take 20mg vitamin K by mouth in capsule form everyday for 14 continuous days.

Timeline

• Start date: 2009-11-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2010-06-14
• Last updated: 2012-06-12

Locations

1 site across 1 country: United States