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ISRCTN
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ISRCTN54112208
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ClinicalTrials.gov identifier
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Public title
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A study to assess whether complications of anti-coagulation treatment with vitamin K antagonists will diminish by supplementation of vitamin K
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Scientific title
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Acronym
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VIKS-2B
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Serial number at source
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P07.243
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Study hypothesis
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The bleeding complications of treatment with vitamin K antagonists will be less in number and severity when supplementation with vitamin K is given.
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Ethics approval
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Ethics approval received from the Medical Ethics Committee of Leiden University Medical Center on the 4th March 2008.
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Study design
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Randomised double-blind placebo-controlled single-centre trial
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Countries of recruitment
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The Netherlands
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Disease/condition/study domain
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Anti-coagulation treatment
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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01/04/2009
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Anticipated end date
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31/03/2012
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Status of trial
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Ongoing
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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2200 patients
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Interventions
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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-trials.com/ISRCTN37109430: 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)
Control group: placebo 1 dd
The duration of the intervention is flexible; 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 participants will receive the intervention for three and two years, respectively.
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Primary outcome measure(s)
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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.
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Secondary outcome measure(s)
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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.
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Sources of funding
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Netherlands Heart Foundation (Nederlandse Hartstichting) (The Netherlands)
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Trial website
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Publications
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Contact name
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Dr
FJM
van der Meer
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Address
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Leiden University Medical Center
Department of Thrombosis and Heamostasis
P.O. Box 9600
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City/town
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Leiden
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Zip/Postcode
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2300 RC
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Country
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Netherlands
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Tel
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+31 (0)71 526 3901
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Fax
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+31 (0)71 526 6960
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Email
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f.j.m.van_der_meer@lumc.nl
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Sponsor
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Netherlands Heart Foundation (Nederlandse Hartstichting) (The Netherlands)
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Address
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P.O. Box 300
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City/town
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The Hague
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Zip/Postcode
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2501 CH
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Country
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Netherlands
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Tel
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+31 (0)70 315 5555
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Fax
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+31 (0)70 335 2826
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Email
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info@hartstichting.nl
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Sponsor website:
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http://www.hartstichting.nl
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Date applied
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17/03/2008
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Last edited
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01/04/2008
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Date ISRCTN assigned
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31/03/2008
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