Vitamin B12 Acceptance and Biomarker Response Study
|ClinicalTrials.gov Identifier: NCT01832129|
Recruitment Status : Completed
First Posted : April 15, 2013
Last Update Posted : June 14, 2016
|Condition or disease||Intervention/treatment||Phase|
|Vitamin B 12 Deficiency||Drug: Oral administration of vitamin B12 Drug: i.m. injection of vitamin B12||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Acceptance and Biomarker Response With Oral vs. Intramuscular Supplementation of Vitamin B12 in Primary Care|
|Study Start Date :||May 2013|
|Primary Completion Date :||December 2015|
|Study Completion Date :||December 2015|
Active Comparator: i.m. injection of Vitamin B12
Weekly i.m. injections of 1 mg Cyanocobolamin after 1, 2, and 3 weeks.
Drug: i.m. injection of vitamin B12
Intramuscular injections of 1 mg vitamin B12 will be performed at days 7, 14, and 21.
Experimental: Oral administration 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.
- Biochemical response to vitamin B12 substitution [ Time Frame: Day 28 ]Vitamin B12 associated biomarkers (Vitamin B12, Holotranscobolamin, Homocystein, MCV, hypersegmentated neutrophils)
- taking and timing adherence with oral vitamin B12 [ Time Frame: day 28 ]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.
- Comparison of patient acceptance of oral vs. i.m. vitamin B12 supplementation [ Time Frame: day 0, day 28 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01832129
|Pharmaceutical Care Research Group|
|Basel, Switzerland, CH-4056|
|Study Chair:||Kurt E Hersberger, Professor||Pharmaceutical Care Research Group|
|Principal Investigator:||Cyrill Jeger, MD|
|Study Director:||Philipp N Walter, MSc||Pharmaceutical Care Research Group|