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

Not Applicable

Completed

• Conditions: Thrombosis
• Interventions: Dietary Supplement: Vitamin K, 20mg

• Registration Number: NCT01143831
• Lead Sponsor: Stephan Moll, MD

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.

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2010-06-11
• Study First Submitted QC: 2010-06-11
• Study First Posted: 2010-06-14
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-11
• Last Update Posted: 2012-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 8

Inclusion Criteria

• Healthy adult male

Exclusion Criteria

• prior history of arterial or venous thrombosis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All study participants	Vitamin K, 20mg	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.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States