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Low dose vitamin K to improve therapeutic quality control of oral anticoagulant treatment: a randomized double-blind placebo controlled trial.


- candidate number1516
- NTR NumberNTR314
- ISRCTNISRCTN14473912
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR9-sep-2005
- Secondary IDsproject 2005.2 
- Public TitleLow dose vitamin K to improve therapeutic quality control of oral anticoagulant treatment: a randomized double-blind placebo controlled trial.
- Scientific TitleLow dose vitamin K to improve therapeutic quality control of oral anticoagulant treatment: a randomized double-blind placebo controlled trial.
- ACRONYMN/A
- hypothesis1. Oral anticoagulant control is less stable at a low average intake of vitamin K;
2. As a consequence, a low dose vitamin K supplement results in a more stable anticoagulant effect in patients using vitamin K antagonists (VKA);
3. Dietary intake of vitamin K is associated with sensitivity to VKA and stability of anticoagulant treatment;
4. Polymorphisms of the VKORC1 gene are associated with sensitivity to VKA and stability of anticoagulant treatment.
- Healt Condition(s) or Problem(s) studiedAnticoagulants, Thrombosis, Embolus
- Inclusion criteria1. Patients treated at the Leiden anticoagulation clinic with an indication for long-term oral anticoagulant therapy using the vitamin K antagonist phenprocoumon;
2. Age between 18 and 80 years;
3. Informed consent.
- Exclusion criteria1. Treatment by a medical specialist for liver failure;
2. Haemo- or peritoneal dialysis;
3. Pregnancy or a planned pregnancy, puerperium;
4. Any chronic condition with an expected median survival of less than 6 months an expectedinterruption of oral anticoagulant treatment of more than 1 week;
5. Self-management of oral anticoagulant therapy;
6. Other drugs affecting hemostasis (aspirin, heparin, clopidogrel).
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 16-nov-2004
- planned closingdate1-jun-2006
- Target number of participants200
- Interventions1. Treatment group: 100 microgram vitamin K for 24 weeks;
2. Placebo group: placebo for 24 weeks.
- Primary outcome1. Quality of anticoagulant treatment;
2. Expressed as time in therapeutic range.
- Secondary outcome1. Number of INRs in therapeutic range;
2. Bleeding and thromboembolic complications.
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIES Eva Rombouts
- CONTACT for SCIENTIFIC QUERIESDr. Felix J.M. Meer, van der
- Sponsor/Initiator Leiden University Medical Center (LUMC), Department of Hematology
- Funding
(Source(s) of Monetary or Material Support)
Dutch Thrombosis Foundation
- PublicationsJ Thromb Haemost. 2007 Oct;5(10):2043-8. Epub 2007 Jul 31.
- Brief summaryBackground:
It has been shown that oral anticoagulant control is less stable at a low dietary intake of vitamin K.
We hypothesize that a low dose vitamin K supplement results in a more stable anticoagulation in patients using vitamin K antagonists.
The primary objective of this study:
is to test this hypothesis clinically.


Methods:
The study is a double blind, randomized, placebo controlled trial in patients who use phenprocoumon and have an indication for long-term oral anticoagulant treatment.
Two hundred patients will be randomized to receive adjusted-dose phenprocoumon and a daily vitamin K supplement of 100 micrograms or to receive adjusted-dose phenprocoumon and placebo for 24 weeks.
The primary endpoint is the percentage of time the INR is within the therapeutic range.
- Main changes (audit trail)
- RECORD9-sep-2005 - 18-nov-2008


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