How Many Patients Are in Need of Vitamin B12 Injections?

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by University of Aarhus.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00326833
First received: May 16, 2006
Last updated: August 7, 2008
Last verified: August 2008

May 16, 2006
August 7, 2008
January 2006
December 2010   (final data collection date for primary outcome measure)
  • Change in plasma cobalamins [ Time Frame: Every month ] [ Designated as safety issue: Yes ]
  • Change in plasma methylmalonic acid [ Time Frame: Every month ] [ Designated as safety issue: Yes ]
  • Change in plasma holotranscobalamin [ Time Frame: Every month ] [ Designated as safety issue: Yes ]
  • Change in plasma cobalamins
  • Change in plasma methylmalonic acid
  • Change in plasma holotranscobalamin
Complete list of historical versions of study NCT00326833 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
How Many Patients Are in Need of Vitamin B12 Injections?
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.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Vitamin B12 Deficiency
Drug: vitamin B12
9 µg vitamin B12 three times daily for two days (CobaSorb)
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
50
December 2010
December 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00326833
2005-0198
Not Provided
Anne-Mette Hvas, Aarhus University
University of Aarhus
Not Provided
Principal Investigator: Anne-Mette Hvas, MD, PhD Aarhus University Hospital
University of Aarhus
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP