Low dose vitamin K to improve therapeutic quality control of oral anticoagulant treatment: a randomised double-blind placebo controlled trial

ISRCTN ISRCTN14473912
DOI https://doi.org/10.1186/ISRCTN14473912
Secondary identifying numbers Project 2005.2; NTR314
Submission date
20/12/2005
Registration date
20/12/2005
Last edited
15/08/2008
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 F.J.M. van der Meer
Scientific

Leiden University Medical Center
Department of Hematology
P.O. Box 9600
Leiden
2300 RC
Netherlands

+31 (0)71 5263901
f.j.m.van_der_meer@lumc.nl

Study information

Study designRandomised, double-blinded, placebo controlled parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectives1. Oral anticoagulant control is less stable at a low average intake of vitamin K
2. As a consequence, a low dose vitamin K supplement results in a more stable anticoagulant effect in patients using vitamin K antagonists (VKA)
3. Dietary intake of vitamin K is associated with sensitivity to VKA and stability of anticoagulant treatment
4. Polymorphisms of the VKORC1 gene are associated with sensitivity to VKA and stability of anticoagulant treatment
Ethics approval(s)Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studiedThrombosis, emboly, anticoagulant treatment
Intervention1. Treatment group: 100 microgram vitamin K for 24 weeks
2. Placebo group: placebo for 24 weeks
Intervention typeSupplement
Primary outcome measure1. Quality of anticoagulant treatment
2. Expressed as time in therapeutic range
Secondary outcome measures1. Number of international normalised ratios (INRs) in therapeutic range
2. Bleeding and thromboembolic complications
Overall study start date16/11/2004
Completion date01/06/2006

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit80 Years
SexAll
Target number of participants200
Key inclusion criteria1. Patients treated at the Leiden anticoagulation clinic with an indication for long-term oral anticoagulant therapy using the vitamin K antagonist phenprocoumon
2. Age between 18 and 80 years
3. Informed consent
Key exclusion criteria1. Treatment by a medical specialist for liver failure
2. Haemo or peritoneal dialysis
3. Pregnancy or a planned pregnancy, puerperium
4. Any chronic condition with an expected median survival of less than 6 months
an expected interruption of oral anticoagulant treatment of more than 1 week
5. Self-management of oral anticoagulant therapy
6. Other drugs affecting haemostasis (aspirin, heparin, clopidogrel)
Date of first enrolment16/11/2004
Date of final enrolment01/06/2006

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Leiden University Medical Center
Leiden
2300 RC
Netherlands

Sponsor information

Funders

Funder type

Charity

Dutch Thrombosis Foundation (Trombosestichting Nederland) (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
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