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

This study has been completed.
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by:
Hospital de Clinicas de Porto Alegre Identifier:
First received: July 20, 2006
Last updated: May 5, 2008
Last verified: May 2008
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: 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

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.
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Please refer to this study by its identifier: 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 Identifier (NCT Number): Identifier: NCT00355290     History of Changes
Other Study ID Numbers: HCPA2006.01
Study First Received: July 20, 2006
Last Updated: May 5, 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
Coagulants processed this record on April 26, 2017