Can Recombinant Human Intrinsic Factor Be Used for Evaluation of the Vitamin B12 Absorption?

This study has been completed.
Sponsor:
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00279552
First received: January 17, 2006
Last updated: NA
Last verified: January 2006
History: No changes posted

January 17, 2006
January 17, 2006
April 2004
Not Provided
Change in holotrancobalamin
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Can Recombinant Human Intrinsic Factor Be Used for Evaluation of the Vitamin B12 Absorption?
Can Recombinant Human Intrinsic Factor Be Used for Evaluation of the Vitamin B12 Absorption?

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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Vitamin B12 Deficiency
Drug: Recombinant human intrinsic factor
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
37
December 2004
Not Provided

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00279552
20030267
Not Provided
Not Provided
University of Aarhus
Not Provided
Principal Investigator: Anne-Mette Hvas, MD, Ph.D. Aarhus University Hospital
University of Aarhus
January 2006

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