NCT04243707

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 20, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 28, 2020

Completed
Last Updated

February 12, 2020

Status Verified

February 1, 2020

Enrollment Period

2 years

First QC Date

January 20, 2020

Last Update Submit

February 10, 2020

Conditions

Vitamin B 12 Deficiency

Outcome Measures

Primary Outcomes (2)

  • 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

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

potential cobalamin deficiency

You may qualify if:

  • potential cobalamin deficiency

You may not qualify if:

  • refusal to take part in a survey

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pharmaceutical Care Research Group

Basel, 4056, Switzerland

Location

MeSH Terms

Conditions

Vitamin B 12 Deficiency

Condition Hierarchy (Ancestors)

Vitamin B DeficiencyAvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Isabelle Arnet, PD Dr.

    Pharmaceutical Care Research Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2020

First Posted

January 28, 2020

Study Start

January 1, 2017

Primary Completion

December 31, 2018

Study Completion

November 30, 2019

Last Updated

February 12, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)