Clinical trial NCT02804841: Effects of Vitamin D3 Supplementation on Cognitive Function in Community Dwelling Older Adults
Official title: D-activating Decline- Exploring the Effects of Vitamin D3 Supplementation on Cognitive Function in Community Dwelling Healthy Older Adults- A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Vitamin D supplementation
Cognitive function
Physical function
Successful ageing
Prevention
Cholecalciferol
Dementia
Muscle mass
Lead sponsor: University of Dublin, Trinity College
Sponsor class: OTHER
First posted: 2016-06-17
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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
* 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

Primary outcomes:
measure: Global Cognitive Function
timeFrame: 26 weeks
measure: Executive Function
timeFrame: 26 weeks
measure: Memory
timeFrame: 26 weeks
measure: Attention and Visual Reasoning
timeFrame: 26 weeks
Secondary outcomes:
measure: Muscle strength
timeFrame: 26 weeks
measure: Physical function
timeFrame: 26 weeks
measure: Systemic inflammation
timeFrame: 26 weeks
measure: Change in Blood Level of Vitamin D (25-hydroxyvitamin D)
timeFrame: 0, 12 and 26 weeks
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: University of Dublin, Trinity College
Study officials:
affiliation: The University of Dublin, Trinity College
name: Maria O'Sullivan, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Dublin, Trinity College
name: Brian Lawlor, MD
role: PRINCIPAL_INVESTIGATOR
References: