Healthy
Conditions
Keywords
Vitamin D supplementation, Cognitive function, Physical function, Successful ageing, Prevention, Cholecalciferol, Dementia, Muscle mass
Brief 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. 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.
Interventions
DIETARY_SUPPLEMENTCholecalciferol -Vitamin D3
OTHERPlacebo -gel capsule containing no vitamin D.
Sponsors
University of Dublin, Trinity College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
60 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Attention and Visual Reasoning | 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 |
| Global Cognitive Function | 26 weeks | Global cognitive function will be assessed using the validated Montreal Cognitive Assessment for all participants |
| Executive Function | 26 weeks | Executive function will be assessed according to the validated Trails Making Task Part A and B |
| Memory | 26 weeks | Episodic memory will be assessed according to the Wescher Memory Scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Muscle strength | 26 weeks | Muscle strength in the participants will be assessed using a clinical dynamometer to measure grip strength |
| Physical function | 26 weeks | Physical function will be assessed using the Timed up and Go measure |
| Systemic inflammation | 26 weeks | Serum will be analysed for levels of specific cytokines |
| Change in Blood Level of Vitamin D (25-hydroxyvitamin D) | 0, 12 and 26 weeks | Serum will be analysed for change in levels from baseline |
Countries
Ireland
Outcome results
None listed