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ISRCTN
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ISRCTN37109430
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ClinicalTrials.gov identifier
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Public title
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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
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Scientific title
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Acronym
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VIKS-2A
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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 anti-coagulation treatment with vitamin K antagonists will be more stable and safer with the supplementation of a low daily dose of vitamin K.
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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-coagulant treatment
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Participants - inclusion criteria
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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
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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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01/04/2008
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Anticipated end date
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31/03/2009
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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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400 patients
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Interventions
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The participants will be randomly allocated to the following four groups in equal numbers:
Group 1: 100 µg vitamin K1 (oral), 1 capsule per day (1 dd)
Group 2: 150 µg vitamin K1 (oral), 1 dd
Group 3: 200 µg vitamin K1 (oral), 1 dd
Control group: placebo (oral), 1 dd
The duration of the treatment is flexible, as is the inclusion period. Follow-up will take place six months after the closure of the inclusion period. This means the first patients will receive vitamin K or placebo for six months and the time the inclusion will take. The last patients will only receive vitamin K or placebo for six months.
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Primary outcome measure(s)
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Quality of anti-coagulant treatment expressed as time in therapeutic range. Duration of follow-up: until six months after the closure of the inclusion period.
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Secondary outcome measure(s)
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Number of INRs in therapeutic range. Duration of follow-up: until six months after the closure of the inclusion 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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