Cobalamin Deficiency - Diagnosis and Therapy

Diagnostics and Therapy of a Cobalamin Deficiency

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.

Study Overview

• Status: Completed
• Conditions: Vitamin B 12 Deficiency

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 Type: Observational
• Enrollment (Actual): 3000

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4056
    • Pharmaceutical Care Research Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

potential cobalamin deficiency

Description

Inclusion Criteria:

• potential cobalamin deficiency

Exclusion Criteria:

• refusal to take part in a survey

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
diagnostic strategies	Sensitivity and specificity of 4 different diagnostic strategies compared to the simultaneous determination of vitamin B12 and holotranscobalamin.	2017 - 2018
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

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Isabelle Arnet, PD Dr., Pharmaceutical Care Research Group

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): November 30, 2019

Study Registration Dates

• First Submitted: January 20, 2020
• First Submitted That Met QC Criteria: January 23, 2020
• First Posted (Actual): January 28, 2020

Study Record Updates

• Last Update Posted (Actual): February 12, 2020
• Last Update Submitted That Met QC Criteria: February 10, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Vitamin B Deficiency; Vitamin B 12 Deficiency
• Other Study ID Numbers: 2019-01295

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No