Vitamin B12 DeficiencyPhase 4NCT00326833
How Many Patients Are in Need of Vitamin B12 Injections?
A Phase 4 study testing vitamin B12 in people with Vitamin B12 Deficiency, run by University of Aarhus at 1 site in Denmark.
Trial summary
The clinical consequences of vitamin B12 deficiency include megaloblastic anemia and neurological disorders. Therefore, a proper and timely diagnosis and treatment is important. The use of sensitive biochemical markers such as methylmalonic acid for the diagnosis of vitamin B12 deficiency have increased since the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitamin B12 Deficiency
- What is being tested?
- vitamin B12
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2006to Dec 2010
- 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
- Above 17 years old
- Have received vitamin B12 treatment for at least one year
- Capable of reading and understanding Danish
Who cannot join
- Pregnant or nursing women
- Not capable of giving informed consent
- Acute infection during the 3-day examination of vitamin B12 absorption
Trial locations and contacts
1 site in 1 country.
About this study
The clinical consequences of vitamin B12 deficiency include megaloblastic anemia and neurological disorders. Therefore, a proper and timely diagnosis and treatment is important. The use of sensitive biochemical markers such as methylmalonic acid for the diagnosis of vitamin B12 deficiency have increased since the 1980s. Consequently, the number of individuals treated with vitamin B12 has increased significantly.
The objective of this project is to study the actual need for vitamin B12 injections in the group of individuals who have already started treatment. In order to investigate this, the investigators stop vitamin B12 treatment in this group, and look for signs of vitamin B12 deficiency by monitoring changes in biochemical and hematological markers. Furthermore, they will test if the individuals are able to absorb a physiological dose of vitamin B12 using a recently developed absorption test (CobaSorb). If a physiological dose can be absorbed, the vitamin B12 injections can be replaced with tablets. In the end, the investigators hope to be able to divide the patients into three groups:
Read more
- need life long injections with vitamin B12,
- only need supplementations with a small dose of oral vitamin B12, and
- no need for further vitamin B12 treatment.
The perspective is that the new information from this study might be used for a future strategy for vitamin B12 treatment.
Read the detailed description
The clinical consequences of vitamin B12 deficiency include megaloblastic anemia and neurological disorders. Therefore, a proper and timely diagnosis and treatment is important. The use of sensitive biochemical markers such as methylmalonic acid for the diagnosis of vitamin B12 deficiency have increased since the 1980s. Consequently, the number of individuals treated with vitamin B12 has increased significantly.
The objective of this project is to study the actual need for vitamin B12 injections in the group of individuals who have already started treatment. In order to investigate this, the investigators stop vitamin B12 treatment in this group, and look for signs of vitamin B12 deficiency by monitoring changes in biochemical and hematological markers. Furthermore, they will test if the individuals are able to absorb a physiological dose of vitamin B12 using a recently developed absorption test (CobaSorb). If a physiological dose can be absorbed, the vitamin B12 injections can be replaced with tablets. In the end, the investigators hope to be able to divide the patients into three groups:
- need life long injections with vitamin B12,
- only need supplementations with a small dose of oral vitamin B12, and
- no need for further vitamin B12 treatment.
The perspective is that the new information from this study might be used for a future strategy for vitamin B12 treatment.
- Conditions
- Vitamin B12 Deficiency
- Being tested
- vitamin B12
- Keywords
- Vitamin B12 deficiency, Vitamin B12 absorption, Holotranscobalamin
- 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.
vitamin B12Drug
9 µg vitamin B12 three times daily for two days (CobaSorb)
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in plasma cobalamins
Measured: Every month
Change in plasma methylmalonic acid
Measured: Every month
Change in plasma holotranscobalamin
Measured: Every month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2006 (estimated)
- Study startJan 2006
- Primary completionDec 2010 (estimated)
- Study completionDec 2010 (estimated)
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 B12 DeficiencyStudies 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 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Investigators
- Anne-Mette Hvas, MD, PhD, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00326833
- Sponsor's protocol ID
- 2005-0198
- Status last verified
- Aug 2008
- First submitted
- 16 May 2006
- Last updated
- 8 Aug 2008
- Results posted
- No
Publications
Hvas AM, Morkbak AL, Hardlei TF, Nexo E. The vitamin B12 absorption test, CobaSorb, identifies patients not requiring vitamin B12 injection therapy. Scand J Clin Lab Invest. 2011 Sep;71(5):432-8. doi: 10.3109/00365513.2011.581389. Epub 2011 May 30.
PubMed 21623649
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Many Patients Are in Need of Vitamin B12 Injections?
- ClinicalTrials.gov ID
- NCT00326833
- Acronym / sponsor ID
- 2005-0198
- Conditions
- Vitamin B12 Deficiency
- Keywords
- Vitamin B12 deficiency, Vitamin B12 absorption, Holotranscobalamin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 17 May 2006 (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 clinical consequences of vitamin B12 deficiency include megaloblastic anemia and neurological disorders. Therefore, a proper and timely diagnosis and treatment is important. The use of sensitive biochemical markers such as methylmalonic acid for the diagnosis of vitamin B12 deficiency have increased since the 1980s. Consequently, the number of individuals treated with vitamin B12 has increased significantly.
The objective of this project is to study the actual need for vitamin B12 injections in the group of individuals who have already started treatment. In order to investigate this, the investigators stop vitamin B12 treatment in this group, and look for signs of vitamin B12 deficiency by monitoring changes in biochemical and hematological markers. Furthermore, they will test if the individuals are able to absorb a physiological dose of vitamin B12 using a recently developed absorption test (CobaSorb). If a physiological dose can be absorbed, the vitamin B12 injections can be replaced with tablets. In the end, the investigators hope to be able to divide the patients into three groups:
- need life long injections with vitamin B12,
- only need supplementations with a small dose of oral vitamin B12, and
- no need for further vitamin B12 treatment.
The perspective is that the new information from this study might be used for a future strategy for vitamin B12 treatment.
Detailed description
The clinical consequences of vitamin B12 deficiency include megaloblastic anemia and neurological disorders. Therefore, a proper and timely diagnosis and treatment is important. The use of sensitive biochemical markers such as methylmalonic acid for the diagnosis of vitamin B12 deficiency have increased since the 1980s. Consequently, the number of individuals treated with vitamin B12 has increased significantly.
The objective of this project is to study the actual need for vitamin B12 injections in the group of individuals who have already started treatment. In order to investigate this, the investigators stop vitamin B12 treatment in this group, and look for signs of vitamin B12 deficiency by monitoring changes in biochemical and hematological markers. Furthermore, they will test if the individuals are able to absorb a physiological dose of vitamin B12 using a recently developed absorption test (CobaSorb). If a physiological dose can be absorbed, the vitamin B12 injections can be replaced with tablets. In the end, the investigators hope to be able to divide the patients into three groups:
- need life long injections with vitamin B12,
- only need supplementations with a small dose of oral vitamin B12, and
- no need for further vitamin B12 treatment.
The perspective is that the new information from this study might be used for a future strategy for vitamin B12 treatment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Above 17 years old
- Have received vitamin B12 treatment for at least one year
- Capable of reading and understanding Danish
Key exclusion criteria (3 listed)
- Pregnant or nursing women
- Not capable of giving informed consent
- Acute infection during the 3-day examination of vitamin B12 absorption
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 B129 µg vitamin B12 three times daily for two days (CobaSorb) | Drug | – |
Primary outcome
Change in plasma cobalamins
Time frame: Every month
Change in plasma methylmalonic acid
Time frame: Every month
Change in plasma holotranscobalamin
Time frame: Every month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2008.
- Derived from this study: PubMed 21623649Hvas AM, Morkbak AL, Hardlei TF, Nexo E. The vitamin B12 absorption test, CobaSorb, identifies patients not requiring vitamin B12 injection therapy. Scand J Clin Lab Invest. 2011 Sep;71(5):432-8. doi: 10.3109/00365513.2011.581389. Epub 2011 May 30.
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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.
Anne-Mette Hvas, MD, PhD principal investigator
Aarhus University Hospital
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 vitamin B12 in people with Vitamin B12 Deficiency, run by University of Aarhus at 1 site in Denmark.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 8 Aug 2008. 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 Denmark. 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?
Results are not available in the source record.
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?
Change in plasma cobalamins (time frame: Every month). The study lists 3 primary outcomes in all. 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 NCT00326833, 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 8 Aug 2008.