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 |
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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
Scientific
Leiden University Medical Center
Department of Thrombosis and Heamostasis
P.O. Box 9600
Leiden
2300 RC
Netherlands
Phone | +31 (0)71 526 3901 |
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f.j.m.van_der_meer@lumc.nl |
Study information
Study design | Randomised double-blind placebo-controlled single-centre trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
Scientific title | 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 |
Study acronym | VIKS-2A |
Study objectives | 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(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) studied | 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 |
Primary outcome measure | 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 study start date | 01/04/2008 |
Completion date | 31/03/2009 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Upper age limit | 85 Years |
Sex | Both |
Target number of participants | 400 patients |
Total final enrolment | 400 |
Key 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 |
Key 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 |
Date of first enrolment | 01/04/2008 |
Date of final enrolment | 31/03/2009 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Leiden University Medical Center
Leiden
2300 RC
Netherlands
2300 RC
Netherlands
Sponsor information
Netherlands Heart Foundation (Nederlandse Hartstichting) (The Netherlands)
Charity
Charity
P.O. Box 300
The Hague
2501 CH
Netherlands
Phone | +31 (0)70 315 5555 |
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info@hartstichting.nl | |
Website | http://www.hartstichting.nl |
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 | |
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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 |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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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.