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CompletedNCT02909491Updated May 1, 2017

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

An observational study in Geriatric Disorders, sponsored by University Hospital, Angers. Completed at 1 site in France. Open to participants aged 75 Years and older. Per ClinicalTrials.gov, last updated 2017-05-01.

Sponsored by University Hospital, Angers · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
90
Ages
75 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Geriatric Disorders
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In context

Lead sponsor

University Hospital, Angers is the lead sponsor of 464 studies on the registry; 116 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
75 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients are recruited in geriatric acute care.

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

Exclusion Criteria:

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

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
90 participants (actual)
Patient registry
No

Groups and cohorts

  • Cases

    Inpatient with severe behavioural disorders

  • Controls

    Inpatients without severe behavioural disorder and taking no antipsychotics

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What researchers measure

Primary outcomes

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

    This measurement is assessed by a blood test.

    Time frame: This outcome is assessed at baseline.

Secondary outcomes

  1. Comparison of serum corrected calcium concentration between cases and paired controls.

    This measurement is assessed by a blood test.

    Time frame: This outcome is assessed at baseline.

  2. 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)

    Time frame: This outcome is assessed at baseline.

  3. Comparison of cognitive performance between cases and paired controls.

    Cognitive performance is assessed by the Mini-Mental State Examination (MMSE) score.

    Time frame: This outcome is assessed at baseline.

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Study locations

1 site
  • Angers University Hospital
    Angers, 49933, France
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 1, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02909491
Lead sponsor
University Hospital, Angers
Responsible party
Sponsor
First posted
Sep 21, 2016
Start date
Jun 2016
Primary completion
Apr 27, 2017
Completion
Apr 27, 2017
Last update
May 1, 2017

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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