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

Hospital de Clinicas de Porto Alegre

Status: Completed

Conditions: Blood Coagulation Disorders

Treatments: Behavioral: Changes on Oral Vitamin K Intake

Study type: Interventional

Funder types: Other

Identifiers

NCT00355290

HCPA2006.01

Details and patient eligibility

About

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.

Enrollment: 114 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)