Effects of Vitamin D3 Supplementation on Cognitive Function in Community Dwelling Older Adults

Study Overview
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Brief Summary
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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.

Official Title
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D-activating Decline- Exploring the Effects of Vitamin D3 Supplementation on Cognitive Function in Community Dwelling Healthy Older Adults- A Pilot Study

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Cholecalciferol -Vitamin D3
* Other: Placebo -gel capsule containing no vitamin D.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Community Dwelling healthy volunteers Ability to provide written consent. Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Healthy, Community Dwelling; Aged 60-80 years; Cholecalciferol -Vitamin D3, 4000 international units (IU) on alternating days. | Dietary Supplement: Cholecalciferol -Vitamin D3<br> <br> |
| Placebo Comparator: Placebo<br>Healthy, Community Dwelling; Aged 60-80 years; Placebo -gel capsule containing no vitamin D on alternating days. | Other: Placebo -gel capsule containing no vitamin D.<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin D supplementation, Cognitive function, Physical function, Successful ageing, Prevention, Cholecalciferol, Dementia, Muscle mass