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-2A
Study hypothesis
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.
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-coagulant treatment
Intervention
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.
Intervention type
Supplement
Phase
Not Specified
Drug names
Vitamin K supplementation
Primary outcome measures
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.
Secondary outcome measures
Number of INRs in therapeutic range. Duration of follow-up: until six months after the closure of the inclusion period.
Overall trial start date
01/04/2008
Overall trial end date
31/03/2009
Reason abandoned
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
400 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
01/04/2008
Recruitment end date
31/03/2009
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