Trial | NCT01832129  Report issue

Title

Vitamin B12 Acceptance and Biomarker Response Study
Acceptance and Biomarker Response With Oral vs. Intramuscular Supplementation of Vitamin B12 in Primary Care

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    cyanocobalamin ...

  • Study Participants

    37
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.
Study Started
May 31
2013
Primary Completion
Dec 31
2015
Study Completion
Dec 31
2015
Last Update
Jun 14
2016
Estimate

Drug Oral administration of vitamin B12

Daily high dose oral vitamin B12 (1mg) will be administered over 4 weeks. The patients adherence to this regimen will be monitored with an electronic punch card.

  • Other names: Cyanocobolamin, B12 "Ankermann" 1 mg

Drug i.m. injection of vitamin B12

Intramuscular injections of 1 mg vitamin B12 will be performed at days 7, 14, and 21.

  • Other names: Vitamin B12 intramuscular, Cyanocobolamin, Vitarubin Depot

i.m. injection of Vitamin B12 Active Comparator

Weekly i.m. injections of 1 mg Cyanocobolamin after 1, 2, and 3 weeks.

Oral administration of vitamin B12 Experimental

High dose (1 mg/day) oral Cyanocobolamin will be adminstrated with electronic adherence monitoring.

Criteria 

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
No Results Posted