Can Recombinant Human Intrinsic Factor Be Used for Evaluation of the Vitamin B12 Absorption?
Primary Purpose
Vitamin B12 Deficiency
Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Recombinant human intrinsic factor
Sponsored by
About this trial
This is an interventional diagnostic trial for Vitamin B12 Deficiency focused on measuring Vitamin B12 deficiency, Vitamin B12 malabsorption, Intrinsic factor, Holotranscobalamin
Eligibility Criteria
Inclusion Criteria: Patients suspected to have vitamin B12 deficiency defined as a plasma vitamin B12 below the reference interval (<200 pmol/L). Exclusion Criteria: Patients who were pregnant, nursing or not able to give written informed consent were excluded.
Sites / Locations
- Department for Clinical Biochemistry
Outcomes
Primary Outcome Measures
Change in holotrancobalamin
Secondary Outcome Measures
Full Information
NCT ID
NCT00279552
First Posted
January 17, 2006
Last Updated
January 17, 2006
Sponsor
University of Aarhus
1. Study Identification
Unique Protocol Identification Number
NCT00279552
Brief Title
Can Recombinant Human Intrinsic Factor Be Used for Evaluation of the Vitamin B12 Absorption?
Official Title
Can Recombinant Human Intrinsic Factor Be Used for Evaluation of the Vitamin B12 Absorption?
Study Type
Interventional
2. Study Status
Record Verification Date
January 2006
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Aarhus
4. Oversight
5. Study Description
Brief Summary
Vitamin B12 is an essential nutrient for normal DNA-synthesis and must be supplied by animal products. Vitamin B12 deficiency may cause anemia and irreverible neurological damage. Laboratory tests are used for diagnosis of vitamin B12 deficiency, and following the diagnosis, the cause of the vitamin B12 deficiency has to be clarified. For years a test called Shilling's test has been used for evaluation of the vitamin B12 absorption. However, the Schilling's test is no longer easy accessible because of increasing difficulties to obtain the radioactively labeled vitamin B12 requested, and native human intrinsic factor for Schilling's test II (absorption of vitamin B12 attached to intrinsic factor) is no longer available in most countries. Recently, human intrinsic factor unsaturated with vitamin B12 has been expressed in the plant Arabidopsis thaliana. The purpose of this study was to examine whether recombinant human intrinsic factor is able to promote the uptake of vitamin B12 in patients with evident vitamin B12 deficiency.
Detailed Description
Vitamin B12 is an essential nutrient for normal DNA-synthesis and must be supplied by animal products. Vitamin B12 deficiency may cause anemia and irreverible neurological damage. Laboratory tests are used for diagnosis of vitamin B12 deficiency, and following the diagnosis, the cause of the vitamin B12 deficiency has to be clarified. For years a test called Shilling's test has been used for evaluation of the vitamin B12 absorption. However, the Schilling's test is no longer easy accessible because of increasing difficulties to obtain the radioactively labeled vitamin B12 requested, and native human intrinsic factor for Schilling's test II (absorption of vitamin B12 attached to intrinsic factor) is no longer available in most countries. Recently, human intrinsic factor unsaturated with vitamin B12 has been expressed in the plant Arabidopsis thaliana. The purpose of this study was to examine whether recombinant human intrinsic factor is able to promote the uptake of vitamin B12 in patients with evident vitamin B12 deficiency.
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 malabsorption, Intrinsic factor, Holotranscobalamin
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
37 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Recombinant human intrinsic factor
Primary Outcome Measure Information:
Title
Change in holotrancobalamin
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients suspected to have vitamin B12 deficiency defined as a plasma vitamin B12 below the reference interval (<200 pmol/L).
Exclusion Criteria:
Patients who were pregnant, nursing or not able to give written informed consent were excluded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne-Mette Hvas, MD, Ph.D.
Organizational Affiliation
Aarhus University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department for Clinical Biochemistry
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
12. IPD Sharing Statement
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Can Recombinant Human Intrinsic Factor Be Used for Evaluation of the Vitamin B12 Absorption?
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