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

This study has been completed.
Sponsor:
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00279552
First received: January 17, 2006
Last updated: NA
Last verified: January 2006
History: No changes posted
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Can Recombinant Human Intrinsic Factor Be Used for Evaluation of the Vitamin B12 Absorption?

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Change in holotrancobalamin

Estimated Enrollment: 37
Study Start Date: April 2004
Estimated Study Completion Date: December 2004
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00279552

Locations
Denmark
Department for Clinical Biochemistry
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Investigators
Principal Investigator: Anne-Mette Hvas, MD, Ph.D. Aarhus University Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00279552     History of Changes
Other Study ID Numbers: 20030267
Study First Received: January 17, 2006
Last Updated: January 17, 2006
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by University of Aarhus:
Vitamin B12 deficiency
Vitamin B12 malabsorption
Intrinsic factor
Holotranscobalamin

Additional relevant MeSH terms:
Vitamin B 12 Deficiency
Deficiency Diseases
Vitamin B Deficiency
Hydroxocobalamin
Vitamin B 12
Vitamin B Complex
Vitamins
Avitaminosis
Malnutrition
Nutrition Disorders
Growth Substances
Hematinics
Hematologic Agents
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014