Cobalamin Deficiency - Diagnosis and Therapy

Completed

• Conditions: Vitamin B 12 Deficiency

• Registration Number: NCT04243707
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2017-01-01
• Primary Completion: 2018-12-31
• Study Completion: 2019-11-30
• Study First Submitted: 2020-01-20
• Study First Submitted QC: 2020-01-23
• Study First Posted: 2020-01-28
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-10
• Last Update Posted: 2020-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

• potential cobalamin deficiency

Exclusion Criteria

• refusal to take part in a survey

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Pharmaceutical Care Research Group; 🇨🇭 Basel, Switzerland