|- candidate number||12903|
|- NTR Number||NTR3485|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||18-jun-2012|
|- Secondary IDs||P10.177 METC LUMC|
|- Public Title||Gerandomiseerde vergelijkende studie naar verschillen tussen de biologische beschikbaarheid en de effectiviteit van vitamine K drank en vitamine K tabletten.|
|- Scientific Title||Randomised trial to investigate possible differences in bioavailability and effectiveness between vitamin K solution in oil and vitamin K tablets.|
|- hypothesis||The bioavailability and effectiveness of vitamin K tablets and solution are comparable.|
|- Healt Condition(s) or Problem(s) studied||Coumarin, Vitamin K antagonist, Vitamin K|
|- Inclusion criteria||1. Healthy subjects;|
2. Patients being treated with phenprocoumon undergoing an invasive diagnostic or therapeutic procedure for which reducing of the INR is necessary;
3. Patients being treated with phenprocoumon having an INR above 7.0 for which reducing with vitamin K is necessary;
4. Age 18 years or older;
5. Informed consent.
|- Exclusion criteria||1. Being treated for liver failure;|
2. Pregancy, pregnancy wish or lactational period;
3. Hemodialysis or peritoneal dialysis;
4. Participation in the self management program;
5. Inability to take care of own medication and/or proven non-compliance with treatment protocols.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||18-jul-2011|
|- planned closingdate||1-jun-2013|
|- Target number of participants||165|
|- Interventions||Administration of vitamin K tablets or solution.|
|- Primary outcome||1. The difference between vitamin K levels in blood 4 hours after taking vitamin K tablets in comparison with vitamin K solution;|
2. The difference in the number of INR-values lower than 2.0 when comparing vitamin K tablets with vitamin K solution in oil after 24 and 48 hours;
3. Difference in the decrease of INRs 24 hours after taking either vitamin K tablets or solution.
The difference in the number of INRs lower than 2.0 when comparing vitamin K tablets and solution after 24 and 48 hours.
|- Secondary outcome||1. The difference between area under the curve measured over 24 hours after taking vitamin K tablets in comparisson with vitamin K solution;|
2. The difference in increase of the vitamin K levels in the blood 24 hours after taking either vitamin K tablets solution.
|- Timepoints||Step 1: 0h; 2h; 4h; 6h; 24h;|
Step 2: 0h; 24h; 48h;
Step 3: 0h; 24h; 48h.
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Dr. Felix J.M. Meer, van der|
|- CONTACT for SCIENTIFIC QUERIES||Dr. Felix J.M. Meer, van der|
|- Sponsor/Initiator ||Leiden University Medical Center (LUMC)|
(Source(s) of Monetary or Material Support)
|Netherlands Heart Foundation (NHS, Nederlandse Hartstichting)|
|- Brief summary||Vitamin K solution was used for several years to antagonize the treatment with vitamin K antagonists. Vitamin K tablets came into the market as 'vitamin tablets' instead of medicines, but are easier to distribute and do have a longer shelf life. However, they are not shown to be as effective as the oral solution. We perform this study to investigate whether the bioavailability and effectiveness of the tablets and solution are comparable. Patients are therefore recruited from the anticoagulation clinic in Leiden, the Netherlands.|
|- Main changes (audit trail)||27-3-2014: Change in timepoints:
Step 1: 0h;2h;4h;5h;6h;8h;10h; 24h. - AB|
|- RECORD||18-jun-2012 - 28-mrt-2014|