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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02909491
Enrollment
90
Registered
2016-09-21
Start date
2016-06-30
Completion date
2017-04-27
Last updated
2017-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Geriatric Disorders

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.

Interventions

None listed

Sponsors

University Hospital, Angers
Lead SponsorOTHER_GOV

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Comparison of serum ionized calcium concentrations between cases and paired controls.This outcome is assessed at baseline.This measurement is assessed by a blood test.

Secondary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026