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

ISRCTN ISRCTN37109430
DOI https://doi.org/10.1186/ISRCTN37109430
Secondary identifying numbers P07.243
Submission date
17/03/2008
Registration date
31/03/2008
Last edited
23/10/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Haematological Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

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 titleA study to find the optimal dose for vitamin K supplementation in patients being treated with vitamin K antagonists to create an anti-coagulation effect
Study acronymVIKS-2A
Study objectivesThe 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(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-coagulant treatment
InterventionThe 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 typeSupplement
Primary outcome measureQuality 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 measuresNumber of INRs in therapeutic range. Duration of follow-up: until six months after the closure of the inclusion period.
Overall study start date01/04/2008
Completion date31/03/2009

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit85 Years
SexBoth
Target number of participants400 patients
Total final enrolment400
Key inclusion criteria1. 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
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 enrolment01/04/2008
Date of final enrolment31/03/2009

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

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/04/2011 23/10/2020 Yes No

Editorial Notes

23/10/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.