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Vitamin B6 study

A pharmacokinetic study of pyridoxal-5’-phosphate and pyrixodine

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON21970
Enrollment
12
Registered
2017-03-24
Start date
2017-06-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pharmacokinetics, pyridoxine, pyridoxal-5'-phosphate

Interventions

daily intake of 50 mg of pyridoxal-s'-phosphate or 50 mg pyridoxine (active control) during 7 days

Sponsors

Maastricht University, MUMC
Lead Sponsor

Eligibility

Inclusion criteria

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

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 25, alcohol consumption > 2 drinks/day

Design outcomes

Primary

MeasureTime frame
plasma pyridoxine concentration during 4 h after the first inake (pharmacokinetics, AUC), and at days 3 and 7 of the study

Secondary

MeasureTime frame
vitamin B6 vitamers and metabolites such as pyridoxal, pyridoxal-5'-phospate, pyridoxamine, 4-pyridoxic acid

Contacts

Public ContactGeja J. Hageman

Dept. of Pharmacology and Toxicology, Maastricht University, P.O. Box 616,

g.hageman@maastrichtuniversity.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)