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Vitamin B6 study


- candidate number26953
- NTR NumberNTR6446
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-mrt-2017
- Secondary IDsUniversiteit Maastricht METC163051
- Public TitleVitamin B6 study
- Scientific TitleA pharmacokinetic study of pyridoxal-5-phosphate and pyrixodine
- ACRONYM
- hypothesisSupplementation with pyridoxine-5'-phosphate will not lead to an increase in plasma concentrations of pyridoxine
- Healt Condition(s) or Problem(s) studiedPharmacokinetics, Vitamin B6
- Inclusion criteriahealthy, adults, both male and female, aged between 20 and 50 years with normal liver and kidney function, with normal BMI (between 19 and 25), and able to come to the research laboratory on 3 specified occasions within a one week period
- Exclusion criteriause of medication (with the exception of oral contraceptives), use of vitamin supplements during the past 6 months, detectable plasma level of pyridoxine, non-normal liver and kidney functions, BMI <19 or >25, alcohol consumption > 2 drinks/day
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jun-2017
- planned closingdate30-nov-2017
- Target number of participants12
- Interventionsdaily intake of 50 mg of pyridoxal-s'-phosphate or 50 mg pyridoxine (active control) during 7 days
- Primary outcomeplasma pyridoxine concentration during 4 h after the first inake (pharmacokinetics, AUC), and at days 3 and 7 of the study
- Secondary outcomevitamin B6 vitamers and metabolites such as pyridoxal, pyridoxal-5'-phospate, pyridoxamine, 4-pyridoxic acid
- Timepointsday 1: before intake, and 30 min, 60 min, 90 min, 120 min, 150 min, 180 min, 210 min and 240 min after intake
day 3
day 7
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr.ir. Geja J. Hageman
- CONTACT for SCIENTIFIC QUERIESDr.ir. Geja J. Hageman
- Sponsor/Initiator Maastricht University Medical Center (MUMC+), Maastricht University
- Funding
(Source(s) of Monetary or Material Support)
Natuurproducten Nederland (NPN)
- Publications
- Brief summaryIn this study the pharmacokinetics of 50 mg pyridoxal-5'-phosphate after oral intake by adult, healthy volunteers, and after daily supplementation with 50 mg during 3 and 7 days plasma B6 vitamers will be determined. This will be compared to daily intake of 50 mg of pyridoxine. Plasma concentrations of pyridoxine and other relevant B6 vitamers will be analysed.
- Main changes (audit trail)
- RECORD24-mrt-2017 - 29-jun-2017


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl