How Many Patients Are in Need of Vitamin B12 Injections?
Primary Purpose
Vitamin B12 Deficiency
Status
Unknown status
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
vitamin B12
Sponsored by
About this trial
This is an interventional diagnostic trial for Vitamin B12 Deficiency focused on measuring Vitamin B12 deficiency, Vitamin B12 absorption, Holotranscobalamin
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
Sites / Locations
- Anne-Mette Hvas
Outcomes
Primary Outcome Measures
Change in plasma cobalamins
Change in plasma methylmalonic acid
Change in plasma holotranscobalamin
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00326833
Brief Title
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
2. Study Status
Record Verification Date
August 2008
Overall Recruitment Status
Unknown status
Study Start Date
January 2006 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
December 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University of Aarhus
4. Oversight
5. Study Description
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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin B12 Deficiency
Keywords
Vitamin B12 deficiency, Vitamin B12 absorption, Holotranscobalamin
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
vitamin B12
Intervention Description
9 µg vitamin B12 three times daily for two days (CobaSorb)
Primary Outcome Measure Information:
Title
Change in plasma cobalamins
Time Frame
Every month
Title
Change in plasma methylmalonic acid
Time Frame
Every month
Title
Change in plasma holotranscobalamin
Time Frame
Every month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne-Mette Hvas, MD, PhD
Organizational Affiliation
Aarhus University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anne-Mette Hvas
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
21623649
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.
Results Reference
derived
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