How Many Patients Are in Need of Vitamin B12 Injections?

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by University of Aarhus.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT00326833
First received: May 16, 2006
Last updated: August 7, 2008
Last verified: August 2008
  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:

  1. need life long injections with vitamin B12,
  2. only need supplementations with a small dose of oral vitamin B12, and
  3. 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 4

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: How Many Patients Are in Need of Vitamin B12 Injections?

Resource links provided by NLM:


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:
    Drug: vitamin B12
    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:

  1. need life long injections with vitamin B12,
  2. only need supplementations with a small dose of oral vitamin B12, and
  3. 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
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: 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 by University of Aarhus

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Anne-Mette Hvas, Aarhus University
ClinicalTrials.gov Identifier: NCT00326833     History of Changes
Other Study ID Numbers: 2005-0198
Study First Received: May 16, 2006
Last Updated: August 7, 2008
Health Authority: Denmark: Ethics Committee

Keywords provided by University of Aarhus:
Vitamin B12 deficiency
Vitamin B12 absorption
Holotranscobalamin

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

ClinicalTrials.gov processed this record on September 16, 2014