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Completed

NCT Number: NCT02909491

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

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.

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Key information

Conditions

Age range

75 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Angers University Hospital

Angers, 49933, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

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

    Time frame: This outcome is assessed at baseline.

    This measurement is assessed by a blood test.

  2. Comparison of the severity of behavioural disorders between cases and paired controls.

    Time frame: 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)

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

    Time frame: This outcome is assessed at baseline.

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

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 21, 2016
Registry last updated
May 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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