HealthyNCT02804841
Effects of Vitamin D3 Supplementation on Cognitive Function in Community Dwelling Older Adults
A study testing Cholecalciferol -Vitamin D3 in people with Healthy, run by University of Dublin, Trinity College at 1 site in Ireland.
Trial summary
Ireland is predicted to have the highest older adult population growth of any European Union country. A substantial economic and social challenge of this projected growth is the increased incidence of cognitive impairment and the likelihood of progression to dementia. Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Cholecalciferol -Vitamin D3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIreland
- Study dates
- Nov 2015to Nov 2016
- Phase
- Interventional
- 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 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Community Dwelling healthy volunteers
- Ability to provide written consent.
Who cannot join
- Measures low or high serum vitamin D, defined as < 15nmol/L or >125nmol/L
- Current use of supplemental vitamin D ≥800 international units/d
- Screen positive for cognitive impairment using the Telephone Cognitive Screen (TCogS)
- Measured hypercalcaemia, defined as corrected serum calcium > 2.7nmol/l
- Hyperparathyroidism
- Epilepsy
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- Stroke
- Renal disease
- Schizophrenia
- Bipolar affective disorder
- Recurrent psychotic depression
- Alcohol and drug abuse within the past 5 years
- Anti-convulsants
- Anti-psychotic medications
- Significant hearing difficulties even when wearing hearing aid
- Illness that caused permanent decrease in memory or other mental function
Trial locations and contacts
1 site in 1 country.
About this study
Official title: D-activating Decline- Exploring the Effects of Vitamin D3 Supplementation on Cognitive Function in Community Dwelling Healthy Older Adults- A Pilot Study
Ireland is predicted to have the highest older adult population growth of any European Union country. A substantial economic and social challenge of this projected growth is the increased incidence of cognitive impairment and the likelihood of progression to dementia. Dementia's, such as Alzheimer's disease, typically have a long prodromal stage with brain changes identifiable from the earliest stages of neuropathology, providing an opportunity for intervention. Switching to a strategy of earlier identification and prevention would significantly reduce prevalence and the associated cost.
The purpose of this pilot study is to evaluate the use of vitamin D supplements in community dwelling older adults as a lifestyle approach that may support cognitive and physical functioning. The research will incorporate several stages including an initial in-depth screening process, a novel and sensitive cognitive battery, 6 month double blind placebo controlled intervention of vitamin D3 (cholecalciferol) and a concluding participant feedback interview.
These results will be used to assess the feasibility of recruiting and assessing community dwelling older adults for extensive nutrition related cognitive studies.
- Conditions
- Healthy
- Being tested
- Cholecalciferol -Vitamin D3, Placebo -gel capsule containing no vitamin D.
- Keywords
- Vitamin D supplementation, Cognitive function, Physical function, Successful ageing, Prevention, Cholecalciferol, Dementia, Muscle mass
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cholecalciferol -Vitamin D3Dietary supplement
Placebo -gel capsule containing no vitamin D.Other
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Healthy, Community Dwelling; Aged 60-80 years; Cholecalciferol -Vitamin D3, 4000 international units (IU) on alternating days. Receives: Dietary Supplement: Cholecalciferol -Vitamin D3 |
| Placebo | Placebo comparator | Healthy, Community Dwelling; Aged 60-80 years; Placebo -gel capsule containing no vitamin D on alternating days. Receives: Other: Placebo -gel capsule containing no vitamin D. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Cognitive Function
Global cognitive function will be assessed using the validated Montreal Cognitive Assessment for all participants
Measured: 26 weeks
Executive Function
Executive function will be assessed according to the validated Trails Making Task Part A and B
Measured: 26 weeks
Memory
Episodic memory will be assessed according to the Wescher Memory Scale
Measured: 26 weeks
Attention and Visual Reasoning
Attention and visual memory will be assessed using 2 validated measures: the Sustained Attention to Response Task and the Cambridge Mental Disorders of the Elderly Examination Visual Reasoning Test
Measured: 26 weeks
Secondary outcomes (4)
Muscle strength
Muscle strength in the participants will be assessed using a clinical dynamometer to measure grip strength
Measured: 26 weeks
Physical function
Physical function will be assessed using the Timed up and Go measure
Measured: 26 weeks
Systemic inflammation
Serum will be analysed for levels of specific cytokines
Measured: 26 weeks
Change in Blood Level of Vitamin D (25-hydroxyvitamin D)
Serum will be analysed for change in levels from baseline
Measured: 0, 12 and 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2016 (estimated)
- Study startNov 2015
- Primary completionMay 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Dublin, Trinity College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria O'Sullivan, University of Dublin, Trinity College
- Investigators
- Maria O'Sullivan, PhD, Principal investigator, The University of Dublin, Trinity CollegeBrian Lawlor, MD, Principal investigator, The University of Dublin, Trinity College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02804841
- Sponsor's protocol ID
- UniDublinTC
- Status last verified
- Nov 2016
- First submitted
- 20 May 2016
- Last updated
- 22 Nov 2016
- 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 22 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- D-activating Decline- Exploring the Effects of Vitamin D3 Supplementation on Cognitive Function in Community Dwelling Healthy Older Adults- A Pilot Study
- ClinicalTrials.gov ID
- NCT02804841
- Acronym / sponsor ID
- UniDublinTC
- Conditions
- Healthy
- Keywords
- Vitamin D supplementation, Cognitive function, Physical function, Successful ageing, Prevention, Cholecalciferol, Dementia, Muscle mass
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Dublin, Trinity CollegeUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- May 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 17 Jun 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.
Ireland is predicted to have the highest older adult population growth of any European Union country. A substantial economic and social challenge of this projected growth is the increased incidence of cognitive impairment and the likelihood of progression to dementia. Dementia's, such as Alzheimer's disease, typically have a long prodromal stage with brain changes identifiable from the earliest stages of neuropathology, providing an opportunity for intervention. Switching to a strategy of earlier identification and prevention would significantly reduce prevalence and the associated cost.
The purpose of this pilot study is to evaluate the use of vitamin D supplements in community dwelling older adults as a lifestyle approach that may support cognitive and physical functioning. The research will incorporate several stages including an initial in-depth screening process, a novel and sensitive cognitive battery, 6 month double blind placebo controlled intervention of vitamin D3 (cholecalciferol) and a concluding participant feedback interview.
These results will be used to assess the feasibility of recruiting and assessing community dwelling older adults for extensive nutrition related cognitive studies.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Dietary Supplement: Cholecalciferol -Vitamin D3Healthy, Community Dwelling; Aged 60-80 years; Cholecalciferol -Vitamin D3, 4000 international units (IU) on alternating days. |
| Placebo | Placebo comparator | Other: Placebo -gel capsule containing no vitamin D.Healthy, Community Dwelling; Aged 60-80 years; Placebo -gel capsule containing no vitamin D on alternating days. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Community Dwelling healthy volunteers
- Ability to provide written consent.
Key exclusion criteria (16 listed)
- Measures low or high serum vitamin D, defined as < 15nmol/L or >125nmol/L
- Current use of supplemental vitamin D ≥800 international units/d
- Screen positive for cognitive impairment using the Telephone Cognitive Screen (TCogS)
- Measured hypercalcaemia, defined as corrected serum calcium > 2.7nmol/l
- Hyperparathyroidism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cholecalciferol -Vitamin D3 | Dietary supplement | Intervention |
| Placebo -gel capsule containing no vitamin D. | Other | Placebo |
Primary outcome
Global Cognitive Function
Time frame: 26 weeks
Global cognitive function will be assessed using the validated Montreal Cognitive Assessment for all participants
Executive Function
Time frame: 26 weeks
Executive function will be assessed according to the validated Trails Making Task Part A and B
Memory
Time frame: 26 weeks
Episodic memory will be assessed according to the Wescher Memory Scale
Attention and Visual Reasoning
Time frame: 26 weeks
Attention and visual memory will be assessed using 2 validated measures: the Sustained Attention to Response Task and the Cambridge Mental Disorders of the Elderly Examination Visual Reasoning Test
4 secondary outcomes
Muscle strength
Time frame: 26 weeks
Physical function
Time frame: 26 weeks
Systemic inflammation
Time frame: 26 weeks
Change in Blood Level of Vitamin D (25-hydroxyvitamin D)
Time frame: 0, 12 and 26 weeks
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 22 Nov 2016.
- 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.
Maria O'Sullivan, PhD principal investigator
The University of Dublin, Trinity College
Brian Lawlor, MD principal investigator
The University of Dublin, Trinity College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cholecalciferol -Vitamin D3 in people with Healthy, run by University of Dublin, Trinity College at 1 site in Ireland.
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 2 inclusion and 16 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 22 Nov 2016. 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 Ireland. 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. Some participants in this study may receive a placebo. 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?
Global Cognitive Function (time frame: 26 weeks). The study lists 4 primary outcomes in all. 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 22 Nov 2016.