How Many Patients Are in Need of Vitamin B12 Injections? - Full Text View

Sponsored by:	University of Aarhus
Information provided by:	University of Aarhus
ClinicalTrials.gov Identifier:	NCT00326833

Purpose

The clinical consequences of vitamin B12 deficiency include megaloblastic anemia and neurological disorders. Therefore, a proper and timely diagnosis and treatment is important. The use of sensitive biochemical markers such as methylmalonic acid for the diagnosis of vitamin B12 deficiency have increased since the 1980s. Consequently, the number of individuals treated with vitamin B12 has increased significantly.

The objective of this project is to study the actual need for vitamin B12 injections in the group of individuals who have already started treatment. In order to investigate this, the investigators stop vitamin B12 treatment in this group, and look for signs of vitamin B12 deficiency by monitoring changes in biochemical and hematological markers. Furthermore, they will test if the individuals are able to absorb a physiological dose of vitamin B12 using a recently developed absorption test (CobaSorb). If a physiological dose can be absorbed, the vitamin B12 injections can be replaced with tablets. In the end, the investigators hope to be able to divide the patients into three groups:

need life long injections with vitamin B12,
only need supplementations with a small dose of oral vitamin B12, and
no need for further vitamin B12 treatment.

The perspective is that the new information from this study might be used for a future strategy for vitamin B12 treatment.

Condition	Intervention	Phase
Vitamin B12 Deficiency	Drug: vitamin B12	Phase IV

Drug Information available for: Vitamin B 12 Hydroxocobalamin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	How Many Patients Are in Need of Vitamin B12 Injections?

Further study details as provided by University of Aarhus:

Primary Outcome Measures:

Change in plasma cobalamins [ Time Frame: Every month ] [ Designated as safety issue: Yes ]
Change in plasma methylmalonic acid [ Time Frame: Every month ] [ Designated as safety issue: Yes ]
Change in plasma holotranscobalamin [ Time Frame: Every month ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	50
Study Start Date:	January 2006
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Intervention Details:

9 µg vitamin B12 three times daily for two days (CobaSorb)

Detailed Description:

The clinical consequences of vitamin B12 deficiency include megaloblastic anemia and neurological disorders. Therefore, a proper and timely diagnosis and treatment is important. The use of sensitive biochemical markers such as methylmalonic acid for the diagnosis of vitamin B12 deficiency have increased since the 1980s. Consequently, the number of individuals treated with vitamin B12 has increased significantly.

The objective of this project is to study the actual need for vitamin B12 injections in the group of individuals who have already started treatment. In order to investigate this, the investigators stop vitamin B12 treatment in this group, and look for signs of vitamin B12 deficiency by monitoring changes in biochemical and hematological markers. Furthermore, they will test if the individuals are able to absorb a physiological dose of vitamin B12 using a recently developed absorption test (CobaSorb). If a physiological dose can be absorbed, the vitamin B12 injections can be replaced with tablets. In the end, the investigators hope to be able to divide the patients into three groups:

need life long injections with vitamin B12,
only need supplementations with a small dose of oral vitamin B12, and
no need for further vitamin B12 treatment.

The perspective is that the new information from this study might be used for a future strategy for vitamin B12 treatment.

Eligibility

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

Criteria

Inclusion Criteria:

Above 17 years old
Have received vitamin B12 treatment for at least one year
Capable of reading and understanding Danish

Exclusion Criteria:

Pregnant or nursing women
Not capable of giving informed consent
Acute infection during the 3-day examination of vitamin B12 absorption

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00326833

Locations

Denmark
Anne-Mette Hvas
Aarhus N, Denmark, 8200

Sponsors and Collaborators

University of Aarhus

Investigators

Principal Investigator:

Anne-Mette Hvas, MD, PhD

Aarhus University Hospital

More Information

No publications provided

Responsible Party:	Aarhus University ( Anne-Mette Hvas )
Study ID Numbers:	2005-0198
Study First Received:	May 16, 2006
Last Updated:	August 7, 2008
ClinicalTrials.gov Identifier:	NCT00326833 History of Changes
Health Authority:	Denmark: Ethics Committee

Keywords provided by University of Aarhus:

Vitamin B12 deficiency
Vitamin B12 absorption
Holotranscobalamin

Study placed in the following topic categories:

Vitamin B Complex
Malnutrition
Hematinics
Avitaminosis
Vitamins
Hydroxocobalamin

Vitamin B 12
Nutrition Disorders
Vitamin B 12 Deficiency
Trace Elements
Micronutrients
Deficiency Diseases

Additional relevant MeSH terms:

Vitamin B Complex
Vitamin B Deficiency
Hematinics
Avitaminosis
Growth Substances
Hematologic Agents
Hydroxocobalamin
Physiological Effects of Drugs
Vitamin B 12 Deficiency

Vitamin B 12
Pharmacologic Actions
Malnutrition
Therapeutic Uses
Vitamins
Nutrition Disorders
Micronutrients
Deficiency Diseases

ClinicalTrials.gov processed this record on May 07, 2009