Can Recombinant Human Intrinsic Factor Be Used for Evaluation of the Vitamin B12 Absorption?
Information source: University of Aarhus
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Vitamin B12 Deficiency
Intervention: Recombinant human intrinsic factor (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: University of Aarhus Official(s) and/or principal investigator(s):
Anne-Mette Hvas, MD, Ph.D., Principal Investigator, Affiliation: Aarhus University Hospital
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.
Clinical Details
Official title: Can Recombinant Human Intrinsic Factor Be Used for Evaluation of the Vitamin B12 Absorption?
Study design: Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Primary outcome: Change in holotrancobalamin
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Department for Clinical Biochemistry, Aarhus 8000, Denmark
Additional Information
Starting date: April 2004
Ending date: December 2004
Last updated: January 17, 2006
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