No registrations found.
ID
Source
Health condition
pharmacokinetics, pyridoxine, pyridoxal-5'-phosphate
Sponsors and support
Intervention
Outcome measures
Primary outcome
plasma pyridoxine concentration during 4 h after the first inake (pharmacokinetics, AUC), and at days 3 and 7 of the study
Secondary outcome
vitamin B6 vitamers and metabolites such as pyridoxal, pyridoxal-5'-phospate, pyridoxamine, 4-pyridoxic acid
Background summary
In 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.
Study objective
Supplementation with pyridoxine-5'-phosphate will not lead to an increase in plasma concentrations of pyridoxine
Study design
day 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
Intervention
daily intake of 50 mg of pyridoxal-s'-phosphate or 50 mg pyridoxine (active control) during 7 days
Geja J. Hageman
Maastricht 6200 MD
The Netherlands
g.hageman@maastrichtuniversity.nl
Geja J. Hageman
Maastricht 6200 MD
The Netherlands
g.hageman@maastrichtuniversity.nl
Inclusion criteria
healthy, 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 criteria
use 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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6105 |
| NTR-old | NTR6446 |
| Other | METC163051 : Universiteit Maastricht |