NCT01143831

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 14, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

June 12, 2012

Status Verified

June 1, 2012

Enrollment Period

2.3 years

First QC Date

June 11, 2010

Last Update Submit

June 11, 2012

Conditions

Thrombosis

Keywords

Vitamin KThrombosis

Outcome Measures

Primary Outcomes (1)

  • Change in levels and activities due to vitamin K supplementation

    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

    4 weeks

Study Arms (1)

All study participants

EXPERIMENTAL

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

Interventions

Vitamin K, 20mgDIETARY_SUPPLEMENT

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

Also known as: Carlson Vitamin K2 Menatetrenone, in 5mg capsules
All study participants

Eligibility Criteria

Age20 Years - 85 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy adult male

You may not qualify if:

  • prior history of arterial or venous thrombosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Thrombosis

Interventions

Vitamin K

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

NaphthoquinonesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPhytolDiterpenesTerpenesPolycyclic Compounds

Study Officials

  • Stephan Moll, MD

    UNC Chapel Hill Department of Medicine, Division of Hematology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 11, 2010

First Posted

June 14, 2010

Study Start

November 1, 2009

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

June 12, 2012

Record last verified: 2012-06

Locations

US(1)