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

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ClinicalTrials.gov Identifier: NCT00355290
Recruitment Status : Completed
First Posted : July 21, 2006
Last Update Posted : May 8, 2008
Sponsor:
Collaborator:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by:
Hospital de Clinicas de Porto Alegre

Brief Summary:
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 or disease Intervention/treatment Phase
Blood Coagulation Disorders Behavioral: Changes on Oral Vitamin K Intake Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 114 participants
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
Study Start Date : August 2006
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Menadione




Primary Outcome Measures :
  1. Percentage of patients on target International Normalized Ratio (prothrombin time) on day 90th after randomization
  2. Stabilization of International Normalized Ratio (prothrombin time) during follow-up (90 days after randomization)


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

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

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 Posted: July 21, 2006    Key Record Dates
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