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

April 28, 2017 updated by: University Hospital, Angers
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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49933
        • Angers University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

75 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients are recruited in geriatric acute care.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Cases
Inpatient with severe behavioural disorders
Controls
Inpatients without severe behavioural disorder and taking no antipsychotics

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
This outcome is assessed at baseline.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
This outcome is assessed at baseline.
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)
This outcome is assessed at baseline.
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.
This outcome is assessed at baseline.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Angers

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Actual)

April 27, 2017

Study Completion (Actual)

April 27, 2017

Study Registration Dates

First Submitted

September 19, 2016

First Submitted That Met QC Criteria

September 19, 2016

First Posted (Estimate)

September 21, 2016

Study Record Updates

Last Update Posted (Actual)

May 1, 2017

Last Update Submitted That Met QC Criteria

April 28, 2017

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-36

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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