Back to resultsChanges in Oral Vitamin K Intake for Optimization of Chronic Oral Anticoagulation: A Randomized Trial
Primary Purpose
Blood Coagulation Disorders
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Changes on Oral Vitamin K Intake
Sponsored by
About this trial
This is an interventional treatment trial for Blood Coagulation Disorders focused on measuring Chronic Oral Anticoagulation
Eligibility 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.
Sites / Locations
- Hospital de Clínicas de Porto Alegre
Outcomes
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT00355290
First Posted
July 20, 2006
Last Updated
May 5, 2008
Sponsor
Hospital de Clinicas de Porto Alegre
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico
1. Study Identification
Unique Protocol Identification Number
NCT00355290
Brief Title
Changes in Oral Vitamin K Intake for Optimization of Chronic Oral Anticoagulation: A Randomized Trial
Official Title
Changes in Oral Vitamin K Intake for Optimization of Chronic Oral Anticoagulation: A Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hospital de Clinicas de Porto Alegre
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Coagulation Disorders
Keywords
Chronic Oral Anticoagulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
114 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Changes on Oral Vitamin K Intake
Primary Outcome Measure Information:
Title
Percentage of patients on target International Normalized Ratio (prothrombin time) on day 90th after randomization
Title
Stabilization of International Normalized Ratio (prothrombin time) during follow-up (90 days after randomization)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luis E Rohde, MD
Organizational Affiliation
Federal University of Rio Grande do Sul
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-903
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
19738137
Citation
de Assis MC, Rabelo ER, Avila CW, Polanczyk CA, Rohde LE. Improved oral anticoagulation after a dietary vitamin k-guided strategy: a randomized controlled trial. Circulation. 2009 Sep 22;120(12):1115-22, 3 p following 1122. doi: 10.1161/CIRCULATIONAHA.109.849208. Epub 2009 Sep 8.
Results Reference
derived
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Changes in Oral Vitamin K Intake for Optimization of Chronic Oral Anticoagulation: A Randomized Trial
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