Cobalamin Deficiency - Diagnosis and Therapy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04243707|
Recruitment Status : Completed
First Posted : January 28, 2020
Last Update Posted : February 12, 2020
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.
|Condition or disease|
|Vitamin B 12 Deficiency|
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|
|Actual Enrollment :||3000 participants|
|Official Title:||Diagnostics and Therapy of a Cobalamin Deficiency|
|Actual Study Start Date :||January 1, 2017|
|Actual Primary Completion Date :||December 31, 2018|
|Actual Study Completion Date :||November 30, 2019|
- diagnostic strategies [ Time Frame: 2017 - 2018 ]Sensitivity and specificity of 4 different diagnostic strategies compared to the simultaneous determination of vitamin B12 and holotranscobalamin.
- supplementation of cobalamin deficiency [ Time Frame: 2020 ]Patient's awareness of a potential cobalamin deficiency, treatment actually applied - with or without registration, ideal supplementation to achieve best adherence.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04243707
|Pharmaceutical Care Research Group|
|Basel, Switzerland, 4056|
|Principal Investigator:||Isabelle Arnet, PD Dr.||Pharmaceutical Care Research Group|