Cobalamin Deficiency - Diagnosis and Therapy

Vitamin B 12 Deficiency Clinical Trial

Official title:

Diagnostics and Therapy of a Cobalamin Deficiency

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04243707
• Other study ID #: 2019-01295
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: November 30, 2019

Study information

• Verified date: February 2020
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In a retrospective study with existing values of vitamin B12 and holotranscobalamin 4 strategies are simulated and the results and costs are compared.

Generally, cobalamin ist substituted by intramuscular administration. However, oral preparations are also available. Aims of the focus groups are to investigate the awareness of a (potential) deficiency and to identify a therapy for best adherence.

Description:

Various diagnostic strategies exist for the identification of a cobalamin deficiency. In a retrospective study with existing serum values of vitamin B12 and holotranscobalamin 4 strategies are simulated and the results and costs are compared.

A cobalamin deficiency can have various causes: Dietary habits (vegetarian, vegan), advanced age, pernicious anaemia, gastrectomy, drug interactions (metformin, proton pump blocker). Therapy is often performed by intramuscular administration of cobalamin. However, oral preparations are also available in very different dosages. Investigators want to investigate with focus groups whether different patient groups are aware of a (potential) deficiency, how cobalamin is actually substituted (with registered or otherwise acquired products) and which therapy would lead to best adherence.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3000
• Est. completion date: November 30, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• potential cobalamin deficiency

Exclusion Criteria:

• refusal to take part in a survey

Related Conditions & MeSH terms

• Vitamin B 12 Deficiency

Locations

Country	Name	City	State
Switzerland	Pharmaceutical Care Research Group	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	diagnostic strategies	Sensitivity and specificity of 4 different diagnostic strategies compared to the simultaneous determination of vitamin B12 and holotranscobalamin.	2017 - 2018
Primary	supplementation of cobalamin deficiency	Patient's awareness of a potential cobalamin deficiency, treatment actually applied - with or without registration, ideal supplementation to achieve best adherence.	2020