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

NCT ID: NCT01143831

Last Updated: 2012-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2012-03-31

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.

Conditions

Thrombosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Vitamin K, 20mg

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Vitamin K, 20mg

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

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Carlson Vitamin K2 Menatetrenone, in 5mg capsules

Eligibility Criteria

Inclusion Criteria

• Healthy adult male

Exclusion Criteria

• prior history of arterial or venous thrombosis

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Stephan Moll, MD

OTHER

Sponsor Role: lead

Responsible Party

Stephan Moll, MD

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Stephan Moll, MD

Role: PRINCIPAL_INVESTIGATOR

UNC Chapel Hill Department of Medicine, Division of Hematology

Locations

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Countries

United States

Other Identifiers

09-1240

Identifier Type: -

Identifier Source: org_study_id