Changes in Oral Vitamin K Intake for Optimization of Chronic Oral Anticoagulation: A Randomized Trial

May 5, 2008 updated by: Hospital de Clinicas de Porto Alegre
The primary hypothesis of this trial is that changes in oral vitamin K intake, based on simple food registries, may be superior to conventional changes in doses of medications in order to stabilize chronic oral anticoagulation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

114

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • RS
      • Porto Alegre, RS, Brazil, 90035-903
        • Hospital de Clinicas de Porto Alegre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with any clinical indication for chronic oral anticoagulation with one INR level out of target, without a clear clinical cause for INR instability (unplanned changes in coumadin medications, other pharmacological interactions, clinical illnesses and laboratory errors).

Exclusion Criteria:

  • Clinical evidence of bleeding or thrombosis.
  • INR > 4 or INR < 1,5.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Percentage of patients on target International Normalized Ratio (prothrombin time) on day 90th after randomization
Stabilization of International Normalized Ratio (prothrombin time) during follow-up (90 days after randomization)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Clinicas de Porto Alegre

Collaborators

Conselho Nacional de Desenvolvimento Científico e Tecnológico

Investigators

  • Principal Investigator: Luis E Rohde, MD, Federal University of Rio Grande do Sul

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

July 20, 2006

First Submitted That Met QC Criteria

July 20, 2006

First Posted (Estimate)

July 21, 2006

Study Record Updates

Last Update Posted (Estimate)

May 8, 2008

Last Update Submitted That Met QC Criteria

May 5, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCPA2006.01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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