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
Scientific
Leiden University Medical Center
Department of Thrombosis and Heamostasis
P.O. Box 9600
Leiden
2300 RC
Netherlands
| Phone | +31 (0)71 526 3901 |
|---|---|
| f.j.m.van_der_meer@lumc.nl |
Study information
| Study design | Randomised double-blind placebo-controlled single-centre trial |
|---|---|
| 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 | |
| Study acronym | VIKS-2B |
| Study objectives | The 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) studied | Anti-coagulation treatment |
| Intervention | The 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 type | Supplement |
| Primary outcome measure | 1. 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 measures | How 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 date | 01/04/2009 |
| Completion date | 31/03/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 85 Years |
| Sex | Both |
| Target number of participants | 2200 patients |
| Key inclusion criteria | 1. 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 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 | 01/04/2009 |
| Date of final enrolment | 31/03/2012 |
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 |
|---|---|
| info@hartstichting.nl | |
| Website | http://www.hartstichting.nl |
"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 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 |
