Effects of Vitamin D3 Supplementation on Cognitive Function in Community Dwelling Older Adults
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|ClinicalTrials.gov Identifier: NCT02804841|
Recruitment Status : Completed
First Posted : June 17, 2016
Last Update Posted : November 22, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Dietary Supplement: Cholecalciferol -Vitamin D3 Other: Placebo -gel capsule containing no vitamin D.||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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 Start Date :||November 2015|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||November 2016|
Healthy, Community Dwelling; Aged 60-80 years; Cholecalciferol -Vitamin D3, 4000 international units (IU) on alternating days.
Dietary Supplement: Cholecalciferol -Vitamin D3
Placebo Comparator: Placebo
Healthy, Community Dwelling; Aged 60-80 years; Placebo -gel capsule containing no vitamin D on alternating days.
Other: Placebo -gel capsule containing no vitamin D.
- Global Cognitive Function [ Time Frame: 26 weeks ]Global cognitive function will be assessed using the validated Montreal Cognitive Assessment for all participants
- Executive Function [ Time Frame: 26 weeks ]Executive function will be assessed according to the validated Trails Making Task Part A and B
- Memory [ Time Frame: 26 weeks ]Episodic memory will be assessed according to the Wescher Memory Scale
- 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
- Muscle strength [ Time Frame: 26 weeks ]Muscle strength in the participants will be assessed using a clinical dynamometer to measure grip strength
- Physical function [ Time Frame: 26 weeks ]Physical function will be assessed using the Timed up and Go measure
- Systemic inflammation [ Time Frame: 26 weeks ]Serum will be analysed for levels of specific cytokines
- Change in Blood Level of Vitamin D (25-hydroxyvitamin D) [ Time Frame: 0, 12 and 26 weeks ]Serum will be analysed for change in levels from baseline
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02804841
|University of Dublin, Trinity College|
|Principal Investigator:||Maria O'Sullivan, PhD||The University of Dublin, Trinity College|
|Principal Investigator:||Brian Lawlor, MD||The University of Dublin, Trinity College|