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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01143831
Enrollment
8
Registered
2010-06-14
Start date
2009-11-30
Completion date
2012-03-31
Last updated
2012-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thrombosis

Keywords

Vitamin K, Thrombosis

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.

Interventions

DIETARY_SUPPLEMENTVitamin K, 20mg

Subjects will take 20mg vitamin K by mouth in capsule form everyday for 14 continuous days.

Sponsors

Stephan Moll, MD
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
20 Years to 85 Years
Healthy volunteers
Yes

Inclusion criteria

* Healthy adult male

Exclusion criteria

* prior history of arterial or venous thrombosis

Design outcomes

Primary

MeasureTime frameDescription
Change in levels and activities due to vitamin K supplementation4 weeksLevels 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026