Clinical trial NCT00326833: How Many Patients Are in Need of Vitamin B12 Injections?
Official title: How Many Patients Are in Need of Vitamin B12 Injections?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Vitamin B12 Deficiency
Keywords: Vitamin B12 deficiency
Vitamin B12 absorption
Holotranscobalamin
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2006-05-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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 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.

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:

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.

Eligibility criteria: Inclusion Criteria:

* Above 17 years old
* Have received vitamin B12 treatment for at least one year
* Capable of reading and understanding Danish

Exclusion Criteria:

* Pregnant or nursing women
* Not capable of giving informed consent
* Acute infection during the 3-day examination of vitamin B12 absorption

Primary outcomes:
measure: Change in plasma cobalamins
timeFrame: Every month
measure: Change in plasma methylmalonic acid
timeFrame: Every month
measure: Change in plasma holotranscobalamin
timeFrame: Every month
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: Anne-Mette Hvas
Study officials:
affiliation: Aarhus University Hospital
name: Anne-Mette Hvas, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.