A study to assess whether complications of anti-coagulation treatment with vitamin K antagonists will diminish by supplementation of vitamin K

ISRCTN ISRCTN54112208
DOI https://doi.org/10.1186/ISRCTN54112208
Secondary identifying numbers P07.243
Submission date
17/03/2008
Registration date
31/03/2008
Last edited
02/09/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Haematological Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr FJM van der Meer
Scientific

Leiden University Medical Center
Department of Thrombosis and Heamostasis
P.O. Box 9600
Leiden
2300 RC
Netherlands

Phone +31 (0)71 526 3901
Email f.j.m.van_der_meer@lumc.nl

Study information

Study designRandomised double-blind placebo-controlled single-centre trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study acronymVIKS-2B
Study objectivesThe bleeding complications of treatment with vitamin K antagonists will be less in number and severity when supplementation with vitamin K is given.
Ethics approval(s)Ethics approval received from the Medical Ethics Committee of Leiden University Medical Center on the 4th March 2008.
Health condition(s) or problem(s) studiedAnti-coagulation treatment
InterventionThe 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 typeSupplement
Primary outcome measure1. 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 measuresHow 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 study start date01/04/2009
Completion date31/03/2012

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit85 Years
SexBoth
Target number of participants2200 patients
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/04/2009
Date of final enrolment31/03/2012

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Leiden University Medical Center
Leiden
2300 RC
Netherlands

Sponsor information

Netherlands Heart Foundation (Nederlandse Hartstichting) (The Netherlands)
Charity

P.O. Box 300
The Hague
2501 CH
Netherlands

Phone +31 (0)70 315 5555
Email info@hartstichting.nl
Website http://www.hartstichting.nl
ROR logo "ROR" https://ror.org/05nxhgm70

Funders

Funder type

Charity

Netherlands Heart Foundation (Nederlandse Hartstichting) (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan