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

Geriatric Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02909491
• Other study ID #: 2016-36
• Status: Completed
• Phase: N/A
• First received: September 19, 2016
• Last updated: April 28, 2017
• Start date: June 2016
• Est. completion date: April 27, 2017

Study information

• Verified date: September 2016
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: April 27, 2017
• Est. primary completion date: April 27, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Geriatric Disorders

Locations

Country	Name	City	State
France	Angers University Hospital	Angers

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of serum ionized calcium concentrations between cases and paired controls.	This measurement is assessed by a blood test.	This outcome is assessed at baseline.
Secondary	Comparison of serum corrected calcium concentration between cases and paired controls.	This measurement is assessed by a blood test.	This outcome is assessed at baseline.
Secondary	Comparison of the severity of behavioural disorders between cases and paired controls.	The severity of behavioural disorders is assessed by a standardized scale (Frontotemporal Behavioural Rating Scale (FBRS), Lebert F. et Pasquier F., 1998)	This outcome is assessed at baseline.
Secondary	Comparison of cognitive performance between cases and paired controls.	Cognitive performance is assessed by the Mini-Mental State Examination (MMSE) score.	This outcome is assessed at baseline.