Geriatric DisordersNCT02909491
Ionized Calcium and Behavioural Disorders in Older Adults (CALICO Study)
An observational study of Geriatric Disorders, run by University Hospital, Angers at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Geriatric Disorders
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2016to 27 Apr 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients are recruited in geriatric acute care.
Who may be able to join
- 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
Who cannot join
- Inability to understand and speak French
- Opposition to the use of information collected for this research
Trial locations and contacts
1 site in 1 country.
About this 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.
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.
- Conditions
- Geriatric Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cases | Inpatient with severe behavioural disorders | |
| Controls | Inpatients without severe behavioural disorder and taking no antipsychotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of serum ionized calcium concentrations between cases and paired controls.
This measurement is assessed by a blood test.
Measured: This outcome is assessed at baseline.
Secondary outcomes (3)
Comparison of serum corrected calcium concentration between cases and paired controls.
This measurement is assessed by a blood test.
Measured: This outcome is assessed at baseline.
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)
Measured: This outcome is assessed at baseline.
Comparison of cognitive performance between cases and paired controls.
Cognitive performance is assessed by the Mini-Mental State Examination (MMSE) score.
Measured: This outcome is assessed at baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2016 (estimated)
- Study startJun 2016
- Primary completion27 Apr 2017
- Study completion27 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Geriatric DisordersStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02909491
- Sponsor's protocol ID
- 2016-36
- Status last verified
- Sep 2016
- First submitted
- 19 Sep 2016
- Last updated
- 1 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ionized Calcium and Behavioural Disorders in Older Adults (CALICO Study)
- ClinicalTrials.gov ID
- NCT02909491
- Acronym / sponsor ID
- 2016-36
- Conditions
- Geriatric Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Jun 2016
- Primary completion
- 27 Apr 2017 (actual)
- Study completion
- 27 Apr 2017 (actual)
- First posted
- 21 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | –Inpatient with severe behavioural disorders |
| Controls | – | –Inpatients without severe behavioural disorder and taking no antipsychotics |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients are recruited in geriatric acute care.
Key inclusion criteria (8 listed)
- Age 75 years and over
- Cases :
- Controls :
Key exclusion criteria (2 listed)
- Inability to understand and speak French
- Opposition to the use of information collected for this research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Comparison of serum corrected calcium concentration between cases and paired controls.
Time frame: 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.
Comparison of cognitive performance between cases and paired controls.
Time frame: This outcome is assessed at baseline.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Geriatric Disorders, run by University Hospital, Angers at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of serum ionized calcium concentrations between cases and paired controls. (time frame: This outcome is assessed at baseline.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2017.