The bioavailability and effectiveness of vitamin K tablets and solution are comparable.
ID
Bron
Verkorte titel
Aandoening
Anticoagulants.
Vitamin K antagonists.
Vitamin K
Coumarines.
Vitamine K antagonisten.
Vitamine K
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
1. The difference between vitamin K levels in blood 4 hours after taking vitamin K tablets in comparison with vitamin K solution;<br>
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;<br>
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.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
The bioavailability and effectiveness of vitamin K tablets and solution are comparable.
Onderzoeksopzet
Step 1: 0h;2h;4h;5h;6h;8h;10h; 24h
Step 2: 0h; 24h; 48h;
Step 3: 0h; 24h; 48h.
Onderzoeksproduct en/of interventie
Administration of vitamin K tablets or solution.
Publiek
Department of Hematology,
P.O. Box 9600
Felix J.M. Meer, van der
Albinusdreef 2
Leiden 2300 RC
The Netherlands
+31 (0)71 5263901
f.j.m.van_der_meer@lumc.nl
Wetenschappelijk
Department of Hematology,
P.O. Box 9600
Felix J.M. Meer, van der
Albinusdreef 2
Leiden 2300 RC
The Netherlands
+31 (0)71 5263901
f.j.m.van_der_meer@lumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL3353 |
| NTR-old | NTR3485 |
| Ander register | METC LUMC : P10.177 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |