NCT00287313

Brief Summary

The purpose of this study is to determine if daily Vitamin K supplementation stabilizes INRs in patients taking warfarin with a history of frequent dose changes or variable INRs.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2005

Shorter than P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 3, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 6, 2006

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
Last Updated

January 12, 2010

Status Verified

January 1, 2010

Enrollment Period

7 months

First QC Date

February 3, 2006

Last Update Submit

January 11, 2010

Conditions

AnticoagulantsWarfarin

Keywords

Unstable INRsWarfarinVitamin K

Outcome Measures

Primary Outcomes (5)

  • Number of warfarin adjustments required in each phase

  • Time in therapeutic, sub-, and supra-therapeutic range

  • Variance/SD of INRs for each patient

  • Adherence assessed by pill counts and pharmacy record review

  • Thrombotic/bleeding episodes

Interventions

Vitamin KDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient of UNC Anticoagulation Clinic with INR target of 2.0-3.0 and at least 9 months on uninterrupted warfarin
  • Unstable INRs for the past 6 months, defined as a minimum number of warfarin dose changes of 3
  • Patient demonstration of proper POC device technique on 2 measurements during one teaching session with investigator
  • Age greater than or equal to 18 years

You may not qualify if:

  • Stroke or TIA within the previous 12 months
  • VTE within the last 3 months
  • Antiphospholipid antibody syndrome
  • Pregnant patients, since warfarin is contraindicated during pregnancy

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

Interventions

Vitamin K

Intervention Hierarchy (Ancestors)

NaphthoquinonesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPhytolDiterpenesTerpenesPolycyclic Compounds

Study Officials

  • Stephan Moll, M.D.

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 3, 2006

First Posted

February 6, 2006

Study Start

October 1, 2005

Primary Completion

May 1, 2006

Study Completion

May 1, 2006

Last Updated

January 12, 2010

Record last verified: 2010-01

Locations

US(1)