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How Many Patients Are in Need of Vitamin B12 Injections?

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ClinicalTrials.gov Identifier: NCT00326833
Recruitment Status : Unknown
Verified August 2008 by University of Aarhus.
Recruitment status was:  Active, not recruiting
First Posted : May 17, 2006
Last Update Posted : August 8, 2008
Sponsor:
Information provided by:
University of Aarhus

Tracking Information
First Submitted Date  ICMJE May 16, 2006
First Posted Date  ICMJE May 17, 2006
Last Update Posted Date August 8, 2008
Study Start Date  ICMJE January 2006
Estimated Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 7, 2008)
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 16, 2006)
  • Change in plasma cobalamins
  • Change in plasma methylmalonic acid
  • Change in plasma holotranscobalamin
Change History Complete list of historical versions of study NCT00326833 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE How Many Patients Are in Need of Vitamin B12 Injections?
Official Title  ICMJE How Many Patients Are in Need of Vitamin B12 Injections?
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Vitamin B12 Deficiency
Intervention  ICMJE Drug: vitamin B12
9 µg vitamin B12 three times daily for two days (CobaSorb)
Study Arms  ICMJE Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 16, 2006)
50
Original Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2010
Estimated Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00326833
Other Study ID Numbers  ICMJE 2005-0198
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Anne-Mette Hvas, Aarhus University
Study Sponsor  ICMJE University of Aarhus
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Anne-Mette Hvas, MD, PhD Aarhus University Hospital
PRS Account University of Aarhus
Verification Date August 2008

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