D-activating Decline- Exploring the Effects of Vitamin D3 Supplementation on Cognitive Function in Community Dwelling Healthy Older Adults- A Pilot Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Healthy
- Sponsor
- University of Dublin, Trinity College
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Memory
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Maria O'Sullivan
Associate Professor
University of Dublin, Trinity College
Eligibility Criteria
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
- •Renal disease
- •Schizophrenia
- •Bipolar affective disorder
- •Recurrent psychotic depression
- •Alcohol and drug abuse within the past 5 years
Outcomes
Primary Outcomes
Memory
Time Frame: 26 weeks
Episodic memory will be assessed according to the Wescher Memory Scale
Global Cognitive Function
Time Frame: 26 weeks
Global cognitive function will be assessed using the validated Montreal Cognitive Assessment for all participants
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
Executive Function
Time Frame: 26 weeks
Executive function will be assessed according to the validated Trails Making Task Part A and B
Secondary Outcomes
- Physical function(26 weeks)
- Systemic inflammation(26 weeks)
- Muscle strength(26 weeks)
- Change in Blood Level of Vitamin D (25-hydroxyvitamin D)(0, 12 and 26 weeks)