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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
Information provided by:

Study Description
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
Blood Coagulation Disorders Behavioral: Changes on Oral Vitamin K Intake

Study Design

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
Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Menadione
U.S. FDA Resources

Arms and Interventions

Outcome Measures

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)

Eligibility Criteria

Information from the National Library of Medicine

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

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

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
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 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
Vitamin K
Growth Substances
Physiological Effects of Drugs
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action