Clinical Trials Logo

Clinical Trial 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 Trial 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. ;


Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


NCT number NCT00279552
Study type Interventional
Source University of Aarhus
Contact
Status Completed
Phase Phase 2
Start date April 2004
Completion date December 2004

See also
  Status Clinical Trial Phase
Completed NCT02270749 - Vitamin Deficiencies and Suppletion in Morbid Obesity Phase 4
Completed NCT02540642 - Effect of Vitamin B12 Supplementation on Glycaemic Control in Uncontrolled Hyperhomocysteinemic Type 2 Diabetic Patients N/A
Completed NCT00826657 - Vitamin B12 Supplementation Study N/A
Completed NCT00843453 - Long-term Use of Proton Pump Inhibitors May Cause Vitamin B12 Deficiency in the Institutionalized Elderly N/A
Completed NCT01584050 - Relative Bioavailability of Folic Acid and L-5-Methlytetrahydrofolate N/A
Completed NCT01661309 - Supplementary Vitamin B12 Effects on Elevated Homocysteine Levels of Vegetarians - Clinical Trial N/A
Completed NCT01876329 - Autoantibodies to Gastric Parietal Cells in Rheumatoid Arthritis Patients N/A
Completed NCT01876732 - Impact of Vitamin B12 Replacement on Epogen Dosing and Improvement of Quality of Life in Hemodialysis Patients N/A
Active, not recruiting NCT00326833 - How Many Patients Are in Need of Vitamin B12 Injections? Phase 4
Completed NCT00467623 - Holotranscobalamin Remains Unchanged During Pregnancy N/A
Completed NCT02076347 - Comparison of Two Pharmacist-led Population Management Approaches to Increase Monitoring of Vitamin B12 and Serum Creatinine Levels for Patients on Metformin N/A
Completed NCT01297361 - The Association Between Religious Origin and Age, and Vitamin B12 and Folic Acid Plasma Levels in Non Jewish Population in Western Galilee N/A
Completed NCT01136512 - Metformin Use and Vitamin B12 Deficiency N/A
Active, not recruiting NCT04048330 - Periconceptional Surveillance in India
Completed NCT00699478 - Oral Vitamin B12 Administration for Vitamin B12 Deficiency After Total Gastrectomy Phase 2