How Many Patients Are in Need of Vitamin B12 Injections?

NCT00326833 | Unknown Phase 4

• 1 other identifier: 2005-0198
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 1.need life long injections with vitamin B12,
2. 2.only need supplementations with a small dose of oral vitamin B12, and
3. 3.no need for further vitamin B12 treatment.

Conditions

Vitamin B12 Deficiency

Keywords

Vitamin B12 deficiency; Vitamin B12 absorption; Holotranscobalamin

Outcome Measures

Primary Outcomes (3)

• Change in plasma cobalamins

  Every month

• Change in plasma methylmalonic acid

  Every month

• Change in plasma holotranscobalamin

  Every month

Interventions

vitamin B12 DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Anne-Mette Hvas

Aarhus N, 8200, Denmark

Location

Related Publications (1)

• Hvas AM, Morkbak AL, Hardlei TF, Nexo E. The vitamin B12 absorption test, CobaSorb, identifies patients not requiring vitamin B12 injection therapy. Scand J Clin Lab Invest. 2011 Sep;71(5):432-8. doi: 10.3109/00365513.2011.581389. Epub 2011 May 30.

  PMID: 21623649 DERIVED

MeSH Terms

Conditions

Vitamin B 12 Deficiency

Interventions

Vitamin B 12

Condition Hierarchy (Ancestors)

Vitamin B Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Corrinoids; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Anne-Mette Hvas, MD, PhD

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 16, 2006
• First Posted: May 17, 2006
• Study Start: January 1, 2006
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: August 8, 2008

Record last verified: 2008-08

Locations

DK (1)