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A study to find the optimal dose for vitamin K supplementation in patients being treated with vitamin K antagonists to create an anti-coagulation effect

Not Applicable
Completed
Conditions
Anti-coagulant treatment
Haematological Disorders
Other coagulation defects
Registration Number
ISRCTN37109430
Lead Sponsor
etherlands Heart Foundation (Nederlandse Hartstichting) (The Netherlands)
Brief Summary

2011 results in https://pubmed.ncbi.nlm.nih.gov/21193422/ (added 23/10/2020)

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
400
Inclusion Criteria

1. Start 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 anf 3.5
3. Aged 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
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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