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NCT00355290 Clinical Trial

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

Blood Coagulation Disorders Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00355290
Other study ID # HCPA2006.01
Secondary ID
Status Completed
Phase N/A
First received July 20, 2006
Last updated May 5, 2008
Start date August 2006
Est. completion date December 2007

Study information
Verified date May 2008
Source Hospital de Clinicas de Porto Alegre
Contact n/a
Is FDA regulated No
Health authority Brazil: Ministry of Health
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 114
Est. completion date December 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Behavioral:
• Changes on Oral Vitamin K Intake

Locations
Country Name City State
Brazil Hospital de Clínicas de Porto Alegre Porto Alegre RS

Sponsors (2)
Lead Sponsor Collaborator
Hospital de Clinicas de Porto Alegre Conselho Nacional de Desenvolvimento Científico e Tecnológico

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of patients on target International Normalized Ratio (prothrombin time) on day 90th after randomization
Primary Stabilization of International Normalized Ratio (prothrombin time) during follow-up (90 days after randomization)
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