Vitamin B12 Deficiency Clinical Trial
Official title:
How Many Patients Are in Need of Vitamin B12 Injections?
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:
1. need life long injections with vitamin B12,
2. only need supplementations with a small dose of oral vitamin B12, and
3. 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.
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:
1. need life long injections with vitamin B12,
2. only need supplementations with a small dose of oral vitamin B12, and
3. 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.
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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