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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
University of Aarhus
About
Eligibility
Locations
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
May 16, 2006
Last Updated
August 7, 2008
Sponsor
University of Aarhus
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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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