A Phase 4 interventional study of Oral administration of vitamin B12 and i.m. injection of vitamin B12 in Vitamin B 12 Deficiency, sponsored by University Hospital, Basel, Switzerland. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-06-14.
Sponsored by University Hospital, Basel, Switzerland · Phase 4, Interventional, and Treatment
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.
72 studies on the registry are indexed under Vitamin B 12 Deficiency; 10 are open to participants now.
This study's enrollment of 37 is below the median of 65 across 44 interventional studies indexed under Vitamin B 12 Deficiency.
Browse Vitamin B 12 Deficiency studies →University Hospital, Basel, Switzerland is the lead sponsor of 968 studies on the registry; 191 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Weekly i.m. injections of 1 mg Cyanocobolamin after 1, 2, and 3 weeks.
Drug: i.m. injection of vitamin B12
High dose (1 mg/day) oral Cyanocobolamin will be adminstrated with electronic adherence monitoring.
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.
Also known as: Cyanocobolamin, B12 "Ankermann" 1 mg
Intramuscular injections of 1 mg vitamin B12 will be performed at days 7, 14, and 21.
Also known as: Vitamin B12 intramuscular, Cyanocobolamin, Vitarubin Depot
Biochemical response to vitamin B12 substitution
Vitamin B12 associated biomarkers (Vitamin B12, Holotranscobolamin, Homocystein, MCV, hypersegmentated neutrophils)
Time frame: Day 28
taking and timing adherence with oral vitamin B12
Adherence to oral vitamin B12 supplementation will be measured with an electronic adherence monitoring device. The number of doses taken (taking adherence) and the number of doses taken within the defined time-frame (timing adherence) will be measured.
Time frame: day 28
Comparison of patient acceptance of oral vs. i.m. vitamin B12 supplementation
Acceptance of the two routes of administration of vitamin B12 substitution by the patients will be measured by specific questionnaires before and after exposure to the medication in both arms.
Time frame: day 0, day 28
This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.
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University Hospital, Basel, Switzerland