Low dose vitamin K to improve therapeutic quality control of oral anticoagulant treatment: a randomised double-blind placebo controlled trial
ISRCTN | ISRCTN14473912 |
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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
Scientific
Leiden University Medical Center
Department of Hematology
P.O. Box 9600
Leiden
2300 RC
Netherlands
Phone | +31 (0)71 5263901 |
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f.j.m.van_der_meer@lumc.nl |
Study information
Study design | Randomised, double-blinded, placebo controlled parallel group trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | |
Study objectives | 1. 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) studied | Thrombosis, emboly, anticoagulant treatment |
Intervention | 1. Treatment group: 100 microgram vitamin K for 24 weeks 2. Placebo group: placebo for 24 weeks |
Intervention type | Supplement |
Primary outcome measure | 1. Quality of anticoagulant treatment 2. Expressed as time in therapeutic range |
Secondary outcome measures | 1. Number of international normalised ratios (INRs) in therapeutic range 2. Bleeding and thromboembolic complications |
Overall study start date | 16/11/2004 |
Completion date | 01/06/2006 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Upper age limit | 80 Years |
Sex | Both |
Target number of participants | 200 |
Key inclusion criteria | 1. 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 criteria | 1. 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 enrolment | 16/11/2004 |
Date of final enrolment | 01/06/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Leiden University Medical Center
Leiden
2300 RC
Netherlands
2300 RC
Netherlands
Sponsor information
Leiden University Medical Center (LUMC) (The Netherlands)
Charity
Charity
Department of Hematology
P.O. Box 9600
Leiden
2300 RC
Netherlands
Website | http://www.lumc.nl/english/start_english.html |
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https://ror.org/05xvt9f17 |
Funders
Funder type
Charity
Dutch Thrombosis Foundation (Trombosestichting Nederland) (The Netherlands)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |