NCT00355290

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 20, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 21, 2006

Completed
11 days until next milestone

Study Start

First participant enrolled

August 1, 2006

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

May 8, 2008

Status Verified

May 1, 2008

First QC Date

July 20, 2006

Last Update Submit

May 5, 2008

Conditions

Blood Coagulation Disorders

Keywords

Chronic Oral Anticoagulation

Outcome Measures

Primary Outcomes (2)

  • 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)

Interventions

Changes on Oral Vitamin K IntakeBEHAVIORAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • Clinical evidence of bleeding or thrombosis.
  • INR \> 4 or INR \< 1,5.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

Related Publications (1)

  • 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.

    PMID: 19738137DERIVED

MeSH Terms

Conditions

Blood Coagulation Disorders

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Luis E Rohde, MD

    Federal University of Rio Grande do Sul

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 20, 2006

First Posted

July 21, 2006

Study Start

August 1, 2006

Study Completion

December 1, 2007

Last Updated

May 8, 2008

Record last verified: 2008-05

Locations

BR(1)