Ionized Calcium and Behavioural Disorders in Older Adults (CALICO Study)

NCT ID: NCT02909491

Last Updated: 2017-05-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 90 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2017-04-27

Brief Summary

The primary objective of this study is to determine whether geriatric inpatients with severe behavioral disorders exhibit higher serum ionized calcium concentration than geriatric inpatients without behavioral disorders, but no difference in serum calcium or corrected calcium concentrations. The secondary objective of this study is to determine whether the serum ionized calcium concentration is associated with behavioral and cognitive performance among geriatric inpatients.

Detailed Description

Growing attention is paid to the neurological effects of calcium. While calcium is necessary for neuronal physiology, it appears that high serum calcium concentrations may be toxic to neurons. An analysis of the Rotterdam Study showed that, among older adults, higher concentrations of calcium were associated with greater cognitive disorders and faster cognitive decline. Similarly, delirium and behavioural disorders are reported in older adults with hypercalcemia. In contrast, other studies failed to find any association. For example, in France, an analysis of the EPIDOS study found no association between calcium concentration and cognitive performance. Thus, further studies remain necessary to make firmer conclusions about this link. In particular, it is interesting to note that all previous studies have used the serum concentrations of calcium or corrected calcium, but not yet ionized calcium. This assay is yet more reproducible, more sensitive and more correlated with clinical events. We propose that the non-use of ionized calcium assay may explain, at least in part, the discrepancies between previous studies.

Conditions

Geriatric Disorders

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Cases

Inpatient with severe behavioural disorders

No interventions assigned to this group

Controls

Inpatients without severe behavioural disorder and taking no antipsychotics

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Age 75 years and over
• Cases :

• Inpatient with severe behavioural disorders
• Being hospitalized in the geriatric acute care unit of Angers University Hospital, France
• Controls :

• Inpatients without severe behavioural disorder and taking no antipsychotics
• Being hospitalized in the geriatric acute care unit of Angers University Hospital, France
• Paired on age (± 3 years) and gender

Exclusion Criteria

• Inability to understand and speak French
• Opposition to the use of information collected for this research

• Minimum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Angers

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Angers University Hospital

Angers, , France

Countries

France

Other Identifiers

2016-36

Identifier Type: -

Identifier Source: org_study_id