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| Name | Class |
|---|---|
| University of Basel | OTHER |
| Aarelab AG | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral administration of vitamin B12 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Biochemical response to vitamin B12 substitution | Vitamin B12 associated biomarkers (Vitamin B12, Holotranscobolamin, Homocystein, MCV, hypersegmentated neutrophils) | Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | day 28 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kurt E Hersberger, Professor | Pharmaceutical Care Research Group | Study Chair |
| Cyrill Jeger, MD | Principal Investigator | |
| Philipp N Walter, MSc | Pharmaceutical Care Research Group | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pharmaceutical Care Research Group | Basel | Basel | CH-4056 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28421567 | Derived | Metaxas C, Mathis D, Jeger C, Hersberger KE, Arnet I, Walter P. Early biomarker response and patient preferences to oral and intramuscular vitamin B12 substitution in primary care: a randomised parallel-group trial. Swiss Med Wkly. 2017 Apr 7;147:w14421. doi: 10.4414/smw.2017.14421. eCollection 2017. |
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| ID | Term |
|---|---|
| D014806 | Vitamin B 12 Deficiency |
| ID | Term |
|---|---|
| D014804 | Vitamin B Deficiency |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
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| i.m. injection of vitamin B12 | Drug | Intramuscular injections of 1 mg vitamin B12 will be performed at days 7, 14, and 21. |
|
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| 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. |
| day 0, day 28 |
| D009748 |
| Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |