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Clinical Trials/NCT02909491
NCT02909491CompletedNot Applicable

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

University Hospital, Angers1 site in 1 country90 target enrollmentStarted: June 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
90
Locations
1
Primary Endpoint
Comparison of serum ionized calcium concentrations between cases and paired controls.

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
75 Years to — (Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Age 75 years and over
  • •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

Outcomes

Primary Outcomes

Comparison of serum ionized calcium concentrations between cases and paired controls.

Time Frame: This outcome is assessed at baseline.

This measurement is assessed by a blood test.

Secondary Outcomes

  • Comparison of cognitive performance between cases and paired controls.(This outcome is assessed at baseline.)
  • Comparison of the severity of behavioural disorders between cases and paired controls.(This outcome is assessed at baseline.)
  • Comparison of serum corrected calcium concentration between cases and paired controls.(This outcome is assessed at baseline.)

Investigators

Sponsor
University Hospital, Angers
Sponsor Class
Other Gov
Responsible Party
Sponsor

Study Sites (1)

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