Contact information
Type
Scientific
Primary contact
Dr FJM van der Meer
ORCID ID
Contact details
Leiden University Medical Center
Department of Thrombosis and Heamostasis
P.O. Box 9600
Leiden
2300 RC
Netherlands
+31 (0)71 526 3901
f.j.m.van_der_meer@lumc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
P07.243
Study information
Scientific title
Acronym
VIKS-2B
Study hypothesis
The bleeding complications of treatment with vitamin K antagonists will be less in number and severity when supplementation with vitamin K is given.
Ethics approval
Ethics approval received from the Medical Ethics Committee of Leiden University Medical Center on the 4th March 2008.
Study design
Randomised double-blind placebo-controlled single-centre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Anti-coagulation treatment
Intervention
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.
Intervention type
Supplement
Phase
Not Specified
Drug names
Vitamin K supplementation
Primary outcome measures
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 outcome measures
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.
Overall trial start date
01/04/2009
Overall trial end date
31/03/2012
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
2200 patients
Participant 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
Recruitment start date
01/04/2009
Recruitment end date
31/03/2012
Locations
Countries of recruitment
Netherlands
Trial participating centre
Leiden University Medical Center
Leiden
2300 RC
Netherlands
Sponsor information
Organisation
Netherlands Heart Foundation (Nederlandse Hartstichting) (The Netherlands)
Sponsor details
P.O. Box 300
The Hague
2501 CH
Netherlands
+31 (0)70 315 5555
info@hartstichting.nl
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
Netherlands Heart Foundation (Nederlandse Hartstichting) (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary