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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Healthy, Community Dwelling; Aged 60-80 years; Cholecalciferol -Vitamin D3, 4000 international units (IU) on alternating days. |
|
| Placebo | Placebo Comparator | Healthy, Community Dwelling; Aged 60-80 years; Placebo -gel capsule containing no vitamin D on alternating days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cholecalciferol -Vitamin D3 | Dietary Supplement |
| ||
| Placebo -gel capsule containing no vitamin D. |
| Measure | Description | Time Frame |
|---|---|---|
| Global Cognitive Function | Global cognitive function will be assessed using the validated Montreal Cognitive Assessment for all participants | 26 weeks |
| Executive Function | Executive function will be assessed according to the validated Trails Making Task Part A and B | 26 weeks |
| Memory | Episodic memory will be assessed according to the Wescher Memory Scale | 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 | 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Muscle strength | Muscle strength in the participants will be assessed using a clinical dynamometer to measure grip strength | 26 weeks |
| Physical function | Physical function will be assessed using the Timed up and Go measure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria O'Sullivan, PhD | The University of Dublin, Trinity College | Principal Investigator |
| Brian Lawlor, MD | The University of Dublin, Trinity College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Dublin, Trinity College | Dublin | Ireland |
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| ID | Term |
|---|---|
| D003704 | Dementia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Other |
|
| 26 weeks |
| Systemic inflammation | Serum will be analysed for levels of specific cytokines | 26 weeks |
| Change in Blood Level of Vitamin D (25-hydroxyvitamin D) | Serum will be analysed for change in levels from baseline | 0, 12 and 26 weeks |
| D001523 | Mental Disorders |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |