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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | January 17, 2006 | ||||
| Last Updated Date | January 17, 2006 | ||||
| Start Date ICMJE | April 2004 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Change in holotrancobalamin | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Can Recombinant Human Intrinsic Factor Be Used for Evaluation of the Vitamin B12 Absorption? | ||||
| Official Title ICMJE | Can Recombinant Human Intrinsic Factor Be Used for Evaluation of the Vitamin B12 Absorption? | ||||
| 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. |
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| 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. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study | ||||
| Condition ICMJE | Vitamin B12 Deficiency | ||||
| Intervention ICMJE | Drug: Recombinant human intrinsic factor | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 37 | ||||
| Completion Date | December 2004 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | 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. |
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Denmark | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00279552 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | 20030267 | ||||
| Study Sponsor ICMJE | University of Aarhus | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | University of Aarhus | ||||
| Verification Date | January 2006 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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