We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00355290
First Posted: July 21, 2006
Last Update Posted: May 8, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by:
Hospital de Clinicas de Porto Alegre
  Purpose
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.

Condition Intervention
Blood Coagulation Disorders Behavioral: Changes on Oral Vitamin K Intake

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Changes in Oral Vitamin K Intake for Optimization of Chronic Oral Anticoagulation: A Randomized Trial

Resource links provided by NLM:


Further study details as provided by Hospital de Clinicas de Porto Alegre:

Primary Outcome Measures:
  • 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)

Estimated Enrollment: 114
Study Start Date: August 2006
Study Completion Date: December 2007
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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): NCT00355290


Locations
Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, RS, Brazil, 90035-903
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators
Principal Investigator: Luis E Rohde, MD Federal University of Rio Grande do Sul
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00355290     History of Changes
Other Study ID Numbers: HCPA2006.01
First Submitted: July 20, 2006
First Posted: July 21, 2006
Last Update Posted: May 8, 2008
Last Verified: May 2008

Keywords provided by Hospital de Clinicas de Porto Alegre:
Chronic Oral Anticoagulation

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hemostatic Disorders
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Vitamins
Vitamin K
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants