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

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ClinicalTrials.gov Identifier: NCT01143831
Recruitment Status : Completed
First Posted : June 14, 2010
Last Update Posted : June 12, 2012
Sponsor:
Information provided by (Responsible Party):
Stephan Moll, MD, University of North Carolina, Chapel Hill

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.

Condition or disease Intervention/treatment
Thrombosis Dietary Supplement: Vitamin K, 20mg

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Evaluation of Factors II, VII, IX, X, and Proteins C and S, Following High-dose Vitamin K Supplementation
Study Start Date : November 2009
Primary Completion Date : March 2012
Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Menadione
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 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.
Dietary Supplement: Vitamin K, 20mg
Subjects will take 20mg vitamin K by mouth in capsule form everyday for 14 continuous days.
Other Name: Carlson Vitamin K2 Menatetrenone, in 5mg capsules



Primary Outcome Measures :
  1. Change in levels and activities due to vitamin K supplementation [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy adult male

Exclusion Criteria:

  • prior history of arterial or venous thrombosis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01143831


Locations
United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
Stephan Moll, MD
Investigators
Principal Investigator: Stephan Moll, MD UNC Chapel Hill Department of Medicine, Division of Hematology

Responsible Party: Stephan Moll, MD, Associate Professor, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01143831     History of Changes
Other Study ID Numbers: 09-1240
First Posted: June 14, 2010    Key Record Dates
Last Update Posted: June 12, 2012
Last Verified: June 2012

Keywords provided by Stephan Moll, MD, University of North Carolina, Chapel Hill:
Vitamin K
Thrombosis

Additional relevant MeSH terms:
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Vitamins
Vitamin K
Protein C
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants
Anticoagulants
Fibrinolytic Agents