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

Stephan Moll, MD

Status: Completed

Conditions: Thrombosis

Treatments: Dietary Supplement: Vitamin K, 20mg

Study type: Interventional

Funder types: Other

Identifiers

NCT01143831

09-1240

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: Male

Ages: 20 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy adult male

Exclusion criteria

• prior history of arterial or venous thrombosis

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

All study participants

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Vitamin K, 20mg