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

Sponsor
University Hospital, Angers (Other)
Overall Status
Completed
CT.gov ID
NCT02909491
Collaborator
(none)
90
1
10.8
8.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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
    Actual Enrollment :
    90 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    Ionized Calcium and Behavioural Disorders in Older Adults (CALICO Study)
    Study Start Date :
    Jun 1, 2016
    Actual Primary Completion Date :
    Apr 27, 2017
    Actual Study Completion Date :
    Apr 27, 2017

    Arms and Interventions

    Arm Intervention/Treatment
    Cases

    Inpatient with severe behavioural disorders

    Controls

    Inpatients without severe behavioural disorder and taking no antipsychotics

    Outcome Measures

    Primary Outcome Measures

    1. 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 Outcome Measures

    1. 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.

    2. 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)

    3. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    75 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Angers University Hospital Angers France 49933

    Sponsors and Collaborators

    • University Hospital, Angers

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Angers
    ClinicalTrials.gov Identifier:
    NCT02909491
    Other Study ID Numbers:
    • 2016-36
    First Posted:
    Sep 21, 2016
    Last Update Posted:
    May 1, 2017
    Last Verified:
    Sep 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 1, 2017