A study to assess whether complications of anti-coagulation treatment with vitamin K antagonists will diminish by supplementation of vitamin K

Completed

• Conditions: Anti-coagulation treatment; Haematological Disorders; Other coagulation defects

• Registration Number: ISRCTN54112208
• Lead Sponsor: etherlands Heart Foundation (Nederlandse Hartstichting) (The Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03-31
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 2200

Inclusion Criteria

1. Starting treatment with vitamin K antagonists less then four weeks before inclusion
2. Treatment with vitamin K antagonists for a minimal period of six months, with the therapeutic range of International normalised ratio (INR) between 2.5 and 3.5
3. Age between 18 and 85 years, either sex
4. Measurement of the INR by the Thrombosis Service Leiden
5. Informed consent

Exclusion Criteria

1. Treatment for liver failure
2. Dialysis, both peritoneal and haemodialysys
3. Pregnancy, or wish to get pregnant; lactational period
4. Known to have a chronic condition with a life expectancy of less than six months
5. An expected interruption of treatment with oral anti-coagulants for one week or longer
6. Participation in the self-management protocol

Study & Design

• Study Type: Interventional
• Study Design: Not specified