Anti-coagulation treatment Haematological Disorders Other coagulation defects
Conditions
Interventions
The participants will be randomly allocated to the following two groups in equal numbers:
Treatment group: vitamin K, 1 capsule a day (1 dd) in the dose found in VIKS-2A (see http://www.controlled-tr
this depends on the rate of recruitment. We aim to achieve the target number of recruitment in one year, and then the treatment will continue for two years. Therefore, in this case, the first and last
Sponsors
Netherlands Heart Foundation (Nederlandse Hartstichting) (The Netherlands)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Number of (bleeding) complications 2. Severity of (bleeding) complications Duration of follow-up: start of intervention to two years after the end of recruitment period. | — |
Secondary
| Measure | Time frame |
|---|---|
| How do polymorphisms of the enzymes vitamin K epoxide reductase complex subunit 1 (VKORC1) and cytochrome P450 2C9 (CYP2C9) influence the effect of vitamin K supplementation? Duration of follow-up: start of intervention to two years after the end of recruitment period. | — |
Countries
Netherlands
Outcome results
None listed