|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||||||||||||||||
| Sponsored by: |
University of Aarhus |
|---|---|
| Information provided by: | University of Aarhus |
| ClinicalTrials.gov Identifier: | NCT00279552 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Vitamin B12 Deficiency |
Drug: Recombinant human intrinsic factor |
Phase II |
| Study Type: | Interventional |
| Study Design: | Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
| Official Title: | Can Recombinant Human Intrinsic Factor Be Used for Evaluation of the Vitamin B12 Absorption? |
| Estimated Enrollment: | 37 |
| Study Start Date: | April 2004 |
| Estimated Study Completion Date: | December 2004 |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations More Information
| Study ID Numbers: | 20030267 |
| Study First Received: | January 17, 2006 |
| Last Updated: | January 17, 2006 |
| ClinicalTrials.gov Identifier: | NCT00279552 |
| Health Authority: | Denmark: Danish Medicines Agency |
|
Vitamin B12 deficiency Vitamin B12 malabsorption Intrinsic factor Holotranscobalamin |
|
Malnutrition Avitaminosis Hydroxocobalamin Vitamin B 12 |
Nutrition Disorders Vitamin B 12 Deficiency Malabsorption Syndromes Deficiency Diseases |
|
Vitamin B Complex Vitamin B Deficiency Hematinics Therapeutic Uses Growth Substances |
Vitamins Hematologic Agents Physiological Effects of Drugs Micronutrients Pharmacologic Actions |
