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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00355290

Enrollment

114

Registered

2006-07-21

Start date

2006-08-31

Completion date

2007-12-31

Last updated

2008-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Coagulation Disorders

Keywords

Chronic Oral Anticoagulation

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.

Interventions

BEHAVIORALChanges on Oral Vitamin K Intake

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
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)	—

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026