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

This study has been completed.

Sponsors and Collaborators:	Hospital de Clinicas de Porto Alegre Fundo de Incentivo a Pesquisa (FIPE-HCPA) Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq)
Information provided by:	Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:	NCT00355290

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

Genetics Home Reference related topics: hemophilia

MedlinePlus related topics: Bleeding Disorders

Drug Information available for: Vitamin K

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title:	Changes in Oral Vitamin K Intake for Optimization of Chronic Oral Anticoagulation: A Randomized Trial

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00355290

Locations

Brazil, RS
Hospital de Clínicas de Porto Alegre
Porto Alegre, RS, Brazil, 90035-903

Sponsors and Collaborators

Hospital de Clinicas de Porto Alegre

Fundo de Incentivo a Pesquisa (FIPE-HCPA)

Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq)

Investigators

Principal Investigator:

Luis E Rohde, MD

Universidade Federal do Rio Grande do Sul

More Information

Study ID Numbers:	HCPA2006.01
Study First Received:	July 20, 2006
Last Updated:	May 5, 2008
ClinicalTrials.gov Identifier:	NCT00355290
Health Authority:	Brazil: Ministry of Health

Keywords provided by Hospital de Clinicas de Porto Alegre:

Chronic Oral Anticoagulation

Study placed in the following topic categories:

Antiplasmin
Hemorrhagic Disorders
Hematologic Diseases
Blood Coagulation Disorders

Vitamin K
Vascular Diseases
Hemostatic Disorders

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Coagulants
Growth Substances
Hematologic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Hemostatics

Fibrin Modulating Agents
Antifibrinolytic Agents
Therapeutic Uses
Vitamins
Cardiovascular Diseases
Micronutrients

ClinicalTrials.gov processed this record on January 14, 2009