HealthyNCT02832726
TRIM: Danish Form and Dose Study on Vitamin B12
A study testing Vitamin B12 in people with Healthy, run by University of Aarhus.
Trial summary
The study investigates the absorption of different doses of hydroxocobalamin and cyanocobalamin in a vitamin B12-replete Danish population. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Vitamin B12
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Jun 2016
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 18 years old
Who cannot join
- Use of vitamin pills with vitamin B12 within the last two weeks of the study
- Treatment with vitamin B12 injections within the last year
- Known chronic systemic disease
- Not able to give informed consent.
About this study
Official title: TRIM: Danish Form and Dose Study in Vitamin B12
The study investigates the absorption of different doses of hydroxocobalamin and cyanocobalamin in a vitamin B12-replete Danish population.
- Conditions
- Healthy
- Being tested
- Vitamin B12
- Keywords
- absorption of Vitamin B12
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin B12Dietary supplement
Also called Cobalamin
| Study group | Role | What they receive |
|---|---|---|
| cyano-hydroxo B12 | Active comparator | Absorption of 3 doses of 9 ug cyano-B12 and 9 ug hydroxo-B12 for two days (the CobaSorb test). No drugs given. Receives: Dietary Supplement: Vitamin B12 |
| Cyano-B12 doses | Active comparator | Absorption of 3 doses of 3 ug, 6 ug, and 9 ug cyano-B12 for two days (the CobaSorb test). No drugs given. Receives: Dietary Supplement: Vitamin B12 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitamin B12 absorption (increase in holotranscobalamin)
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2016 (estimated)
- Study startJan 2014
- Primary completionMay 2016
- Study completionJun 2016
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 HealthyStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02832726
- Sponsor's protocol ID
- KBA B48 2013
- Status last verified
- Jun 2016
- First submitted
- 28 Jun 2016
- Last updated
- 14 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: No plan at this point
Publications
Greibe E, Mahalle N, Bhide V, Heegaard CW, Naik S, Nexo E. Increase in circulating holotranscobalamin after oral administration of cyanocobalamin or hydroxocobalamin in healthy adults with low and normal cobalamin status. Eur J Nutr. 2018 Dec;57(8):2847-2855. doi: 10.1007/s00394-017-1553-5. Epub 2017 Oct 16.
PubMed 29038891
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRIM: Danish Form and Dose Study in Vitamin B12
- ClinicalTrials.gov ID
- NCT02832726
- Acronym / sponsor ID
- KBA B48 2013
- Conditions
- Healthy
- Keywords
- absorption of Vitamin B12
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- May 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 14 Jul 2016 (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.
The study investigates the absorption of different doses of hydroxocobalamin and cyanocobalamin in a vitamin B12-replete Danish population.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cyano-hydroxo B12 | Active comparator | Dietary Supplement: Vitamin B12Absorption of 3 doses of 9 ug cyano-B12 and 9 ug hydroxo-B12 for two days (the CobaSorb test). No drugs given. |
| Cyano-B12 doses | Active comparator | Dietary Supplement: Vitamin B12Absorption of 3 doses of 3 ug, 6 ug, and 9 ug cyano-B12 for two days (the CobaSorb test). No drugs given. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- At least 18 years old
Key exclusion criteria (4 listed)
- Use of vitamin pills with vitamin B12 within the last two weeks of the study
- Treatment with vitamin B12 injections within the last year
- Known chronic systemic disease
- Not able to give informed consent.
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 |
|---|---|---|
| Vitamin B12Also: Cobalamin | Dietary supplement | Cyano-B12 doses, cyano-hydroxo B12 |
Primary outcome
Vitamin B12 absorption (increase in holotranscobalamin)
Time frame: 3 days
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 Jul 2016.
- Derived from this study: PubMed 29038891Greibe E, Mahalle N, Bhide V, Heegaard CW, Naik S, Nexo E. Increase in circulating holotranscobalamin after oral administration of cyanocobalamin or hydroxocobalamin in healthy adults with low and normal cobalamin status. Eur J Nutr. 2018 Dec;57(8):2847-2855. doi: 10.1007/s00394-017-1553-5. Epub 2017 Oct 16.
- Individual participant dataSharing planned: No. No plan at this point
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin B12 in people with Healthy, run by University of Aarhus.
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 1 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 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Vitamin B12 absorption (increase in holotranscobalamin) (time frame: 3 days). 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 NCT02832726, 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 Jul 2016.