Effect of administration route on the pharmacokinetics of cobalamin in elderly

Effect of administration route on the pharmacokinetics of cobalamin in elderly - Pharmacokinetics of Cobalamin

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON36589

Enrollment

Registered

2011-04-28

Start date

2011-09-01

Completion date

Unknown

Last updated

2025-03-24

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

Conditions

Cobalamin deficiency or Vitamin B12 deficiency

Interventions

Randomsation, first cobalamin dose can be administered by the standard intramuscular injection or by intranasal spray.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Cobalamin deficiency (cobalamin serum level less than 200 pmol/l) - Age 65 years or over - Capable of understanding the study information - informed consent

Exclusion criteria

Exclusion criteria: - Concomitant use of nasally administered medication - Chronic rhinitis - Running nose - Clinical relevant infection - Hemodynamic Instability - Short Nutritional Questionnaire Score (SNAQ) of 3 or over - Use of cobalamin containing dietary supplements - Severe Renal impairment i.e. MDRD less than 20 ml/min - Ethical or medical reasons upon discretion of the investigators

Design outcomes

Primary

Measure	Time frame
The AUC48hours of intramuscular compared with intranasal administration.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)