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Vitamin B12 Acceptance and Biomarker Response Study

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University Hospital Basel

Status and phase

Completed
Phase 4

Conditions

Vitamin B 12 Deficiency

Treatments

Drug: i.m. injection of vitamin B12
Drug: Oral administration of vitamin B12

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01832129
PCRG_VB12_CM

Details and patient eligibility

About

In this study, biomarker response after supplementation with oral and intramuscular vitamin B12 will be compared in a randomized clinical trial. Electronic compliance monitoring will be used to control for non compliance as a possible confounder in oral treatment. Additionally subjective acceptance in terms of presumed preferences will be compared with oral vs. intramuscular supplementation of vitamin B12 in the view of the patient.

Enrollment

37 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • General practitioner's prescription for Vitamin B12 deficiency testing
  • Age> 18 years
  • Ability to give written informed consent
  • Vitamin B12 serum concentrations < 200pmol/l
  • indication for vitamin B12 supplementation according to the General practitioners estimation

Exclusion criteria

  • Patients with incorrect intake of vitamin preparations containing vitamin B12
  • Patients with previously diagnosed dementia
  • Patients with known hereditary transcobalamin transportation defects
  • lack of written and/or oral understanding in German, French, Italian or English languages

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

37 participants in 2 patient groups

i.m. injection of Vitamin B12
Active Comparator group
Description:
Weekly i.m. injections of 1 mg Cyanocobolamin after 1, 2, and 3 weeks.
Treatment:
Drug: i.m. injection of vitamin B12
Oral administration of vitamin B12
Experimental group
Description:
High dose (1 mg/day) oral Cyanocobolamin will be adminstrated with electronic adherence monitoring.
Treatment:
Drug: Oral administration of vitamin B12

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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