NCT00279552

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2004

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 17, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 19, 2006

Completed
Last Updated

January 19, 2006

Status Verified

January 1, 2006

First QC Date

January 17, 2006

Last Update Submit

January 17, 2006

Conditions

Vitamin B12 Deficiency

Keywords

Vitamin B12 deficiencyVitamin B12 malabsorptionIntrinsic factorHolotranscobalamin

Outcome Measures

Primary Outcomes (1)

  • Change in holotrancobalamin

Interventions

Recombinant human intrinsic factorDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients suspected to have vitamin B12 deficiency defined as a plasma vitamin B12 below the reference interval (\<200 pmol/L).

You may not qualify if:

  • Patients who were pregnant, nursing or not able to give written informed consent were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department for Clinical Biochemistry

Aarhus, 8000, Denmark

Location

MeSH Terms

Conditions

Vitamin B 12 Deficiency

Condition Hierarchy (Ancestors)

Vitamin B DeficiencyAvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Anne-Mette Hvas, MD, Ph.D.

    Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 17, 2006

First Posted

January 19, 2006

Study Start

April 1, 2004

Study Completion

December 1, 2004

Last Updated

January 19, 2006

Record last verified: 2006-01

Locations

DK(1)