Vitamin B 12 DeficiencyPhase 4NCT01832129
Vitamin B12 Acceptance and Biomarker Response Study
A Phase 4 study testing Oral administration of vitamin B12 and i.m. injection of vitamin B12 in people with Vitamin B 12 Deficiency, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitamin B 12 Deficiency
- What is being tested?
- Oral administration of vitamin B12 and i.m. injection of vitamin B12
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2013to Dec 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Switzerland1 site
Pharmaceutical Care Research Group
Basel, Basel, CH-4056
About this study
Official title: Acceptance and Biomarker Response With Oral vs. Intramuscular Supplementation of Vitamin B12 in Primary Care
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.
- Conditions
- Vitamin B 12 Deficiency
- Being tested
- Oral administration of vitamin B12, i.m. injection of vitamin B12
- Medical subject headings
- Vitamin B 12 Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral administration of vitamin B12Drug
Also called Cyanocobolamin, B12 "Ankermann" 1 mg
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.
i.m. injection of vitamin B12Drug
Also called Vitamin B12 intramuscular, Cyanocobolamin, Vitarubin Depot
Intramuscular injections of 1 mg vitamin B12 will be performed at days 7, 14, and 21.
| Study group | Role | What they receive |
|---|---|---|
| i.m. injection of Vitamin B12 | Active comparator | Weekly i.m. injections of 1 mg Cyanocobolamin after 1, 2, and 3 weeks. Receives: Drug: i.m. injection of vitamin B12 |
| Oral administration of vitamin B12 | Experimental | High dose (1 mg/day) oral Cyanocobolamin will be adminstrated with electronic adherence monitoring. Receives: Drug: Oral administration of vitamin B12 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical response to vitamin B12 substitution
Vitamin B12 associated biomarkers (Vitamin B12, Holotranscobolamin, Homocystein, MCV, hypersegmentated neutrophils)
Measured: Day 28
Secondary outcomes (2)
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.
Measured: 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.
Measured: day 0, day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2013 (estimated)
- Study startMay 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vitamin B 12 DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- University of Basel, Aarelab AG
- Responsible party
- Principal investigator, Philipp Walter, PhD, University of Basel
- Investigators
- Kurt E Hersberger, Professor, Study chair, Pharmaceutical Care Research GroupCyrill Jeger, MD, Principal investigatorPhilipp N Walter, MSc, Study director, Pharmaceutical Care Research Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01832129
- Sponsor's protocol ID
- PCRG_VB12_CM
- Status last verified
- Jun 2016
- First submitted
- 5 Apr 2013
- Last updated
- 14 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 28421567
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptance and Biomarker Response With Oral vs. Intramuscular Supplementation of Vitamin B12 in Primary Care
- ClinicalTrials.gov ID
- NCT01832129
- Acronym / sponsor ID
- PCRG_VB12_CM
- Conditions
- Vitamin B 12 Deficiency
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- University of Basel, Aarelab AG
- Study start
- May 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 15 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| i.m. injection of Vitamin B12 | Active comparator | Drug: i.m. injection of vitamin B12Weekly i.m. injections of 1 mg Cyanocobolamin after 1, 2, and 3 weeks. |
| Oral administration of vitamin B12 | Experimental | Drug: Oral administration of vitamin B12High dose (1 mg/day) oral Cyanocobolamin will be adminstrated with electronic adherence monitoring. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral administration of vitamin B12Also: Cyanocobolamin, B12 "Ankermann" 1 mgDaily 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. | Drug | Oral administration of vitamin B12 |
| i.m. injection of vitamin B12Also: Vitamin B12 intramuscular, Cyanocobolamin, Vitarubin DepotIntramuscular injections of 1 mg vitamin B12 will be performed at days 7, 14, and 21. | Drug | i.m. injection of Vitamin B12 |
Primary outcome
Biochemical response to vitamin B12 substitution
Time frame: Day 28
Vitamin B12 associated biomarkers (Vitamin B12, Holotranscobolamin, Homocystein, MCV, hypersegmentated neutrophils)
2 secondary outcomes
taking and timing adherence with oral vitamin B12
Time frame: day 28
Comparison of patient acceptance of oral vs. i.m. vitamin B12 supplementation
Time frame: day 0, day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2016.
- Derived from this study: PubMed 28421567Metaxas 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kurt E Hersberger, Professor study chair
Pharmaceutical Care Research Group
Cyrill Jeger, MD principal investigator
Philipp N Walter, MSc study director
Pharmaceutical Care Research Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oral administration of vitamin B12 and i.m. injection of vitamin B12 in people with Vitamin B 12 Deficiency, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemical response to vitamin B12 substitution (time frame: Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01832129, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2016.