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

Not Applicable

Completed

Interventions: Dietary Supplement: Cholecalciferol -Vitamin D3
Other: Placebo -gel capsule containing no vitamin D.

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.

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Intervention	Cholecalciferol -Vitamin D3	Healthy, Community Dwelling; Aged 60-80 years; Cholecalciferol -Vitamin D3, 4000 international units (IU) on alternating days.
Placebo	Placebo -gel capsule containing no vitamin D.	Healthy, Community Dwelling; Aged 60-80 years; Placebo -gel capsule containing no vitamin D on alternating days.

Primary Outcome Measures

Name	Time	Method
Memory	26 weeks	Episodic memory will be assessed according to the Wescher Memory Scale
Global Cognitive Function	26 weeks	Global cognitive function will be assessed using the validated Montreal Cognitive Assessment for all participants
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
Executive Function	26 weeks	Executive function will be assessed according to the validated Trails Making Task Part A and B

Secondary Outcome Measures

Name	Time	Method
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
Muscle strength	26 weeks	Muscle strength in the participants will be assessed using a clinical dynamometer to measure grip strength
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

Receive instant email notifications about changes in this clinical trial

Receive instant email notifications about changes in this clinical trial