A randomised, double blind placebo controlled trial to (A) assess the optimal vitamin K dosage for supplementation, and (B) to access wether complications of anticoagulation treatment will diminish by suppletion of vitamin K.
Phase 4
Completed
- Conditions
- BleedingThrombosis10064477Complicaties van behandeling
- Registration Number
- NL-OMON30852
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 2600
Inclusion Criteria
1. Start treatment with vitamin K antagonists less then 4 weeks before inclusion.
2. Treatment with vitamin K antagonists for a minimal period of 6 months, with the therapeutic range of INR between 2.5 and 3.5.
3. Age between 18 and 85 years.
4. Measurement of the INR by the Thrombosis Service Leiden.
5. Informed consent.
Exclusion Criteria
1. Treatment for liver failure.
2. Dialysys, both peritoneal as hemodialysys.
3. Pregnancy or wish to get pregnant, lactational period.
4. Known to have a chronic condition with a life expectancy of less than 6 months.
5. An expected interruption of treatment with oral anticoagulants for one week or longer.
6. Participation of the self management protocol.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>VIKS-2A:<br /><br>The clinical endpoint of the studies is the stability of<br /><br>anticoagulationtherapy (expressed as the time in therapeutic zone) linked to<br /><br>the dosage of vitamin K.<br /><br>VIKS-2B:<br /><br>The clinical endpoint of the studies is the number of complications of<br /><br>anticoagulationtherapy per 100 patientyears, linked to the dosage of vitamin K.</p><br>
- Secondary Outcome Measures
Name Time Method <p>VIKS-2A and VIKS-2B:<br /><br>The effect of polymorphisms in CYP2C9 and VKORC1 on the sensitivity for VKA and<br /><br>supplementation of vitamin K.</p><br>