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

Vitamin B12 Deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00279552
• Other study ID #: 20030267
• Status: Completed
• Phase: Phase 2
• First received: January 17, 2006
• Last updated: January 17, 2006
• Start date: April 2004
• Est. completion date: December 2004

Study information

• Verified date: January 2006
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Vitamin B 12 Deficiency
• Vitamin B12 Deficiency

Intervention

Drug:
• Recombinant human intrinsic factor

Locations

Country	Name	City	State
Denmark	Department for Clinical Biochemistry	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in holotrancobalamin