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Trial record 2 of 97 for:    calcium cation

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

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ClinicalTrials.gov Identifier: NCT02909491
Recruitment Status : Completed
First Posted : September 21, 2016
Last Update Posted : May 1, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Angers

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
Geriatric Disorders

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
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 : June 2016
Actual Primary Completion Date : April 27, 2017
Actual Study Completion Date : April 27, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium

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



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients are recruited in geriatric acute care.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02909491


Locations
France
Angers University Hospital
Angers, France, 49933
Sponsors and Collaborators
University Hospital, Angers

Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT02909491     History of Changes
Other Study ID Numbers: 2016-36
First Posted: September 21, 2016    Key Record Dates
Last Update Posted: May 1, 2017
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Disease
Pathologic Processes