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

Not Applicable

Completed

• Conditions: Blood Coagulation Disorders

• Registration Number: NCT00355290
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-07-20
• Study First Submitted QC: 2006-07-20
• Study First Posted: 2006-07-21
• Study Start: 2006-08
• Study Completion: 2007-12
• Status Verified: 2008-05
• Last Update Submitted: 2008-05-05
• Last Update Posted: 2008-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Hospital de Clínicas de Porto Alegre; 🇧🇷 Porto Alegre, RS, Brazil