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

Phase 2

Completed

• Conditions: Vitamin B12 Deficiency

• Registration Number: NCT00279552
• Lead Sponsor: University of Aarhus

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.

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.

Study Timeline

• Study Start: 2004-04
• Study Completion: 2004-12
• Status Verified: 2006-01
• Study First Submitted: 2006-01-17
• Study First Submitted QC: 2006-01-17
• Last Update Submitted: 2006-01-17
• Study First Posted: 2006-01-19
• Last Update Posted: 2006-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in holotrancobalamin

Trial Locations

Locations (1)

Department for Clinical Biochemistry; 🇩🇰 Aarhus, Denmark