D-activating Decline- Exploring the Effects of Vitamin D3 Supplementation on Cognitive Function in Community Dwelling Healthy Older Adults- A Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Memory
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 60 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
- •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
Arms & Interventions
Intervention
Healthy, Community Dwelling; Aged 60-80 years; Cholecalciferol -Vitamin D3, 4000 international units (IU) on alternating days.
Intervention: Cholecalciferol -Vitamin D3 (Dietary Supplement)
Placebo
Healthy, Community Dwelling; Aged 60-80 years; Placebo -gel capsule containing no vitamin D on alternating days.
Intervention: Placebo -gel capsule containing no vitamin D. (Other)
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)
Investigators
Maria O'Sullivan
Associate Professor
University of Dublin, Trinity College