How Many Patients Are in Need of Vitamin B12 Injections?

Vitamin B12 Deficiency Clinical Trial

Official title:

How Many Patients Are in Need of Vitamin B12 Injections?

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00326833
• Other study ID #: 2005-0198
• Status: Active, not recruiting
• Phase: Phase 4
• First received: May 16, 2006
• Last updated: August 7, 2008
• Start date: January 2006
• Est. completion date: December 2010

Study information

• Verified date: August 2008
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Locations

Country	Name	City	State
Denmark	Anne-Mette Hvas	Aarhus N

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 plasma cobalamins		Every month	Yes
Primary	Change in plasma methylmalonic acid		Every month	Yes
Primary	Change in plasma holotranscobalamin		Every month	Yes