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

D-activating Decline- Exploring the Effects of Vitamin D3 Supplementation on Cognitive Function in Community Dwelling Healthy Older Adults- A Pilot Study

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 Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Cholecalciferol -Vitamin D3; Other: Placebo -gel capsule containing no vitamin D.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Dublin, Ireland
    • University of Dublin, Trinity College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global Cognitive Function	Global cognitive function will be assessed using the validated Montreal Cognitive Assessment for all participants	26 weeks
Executive Function	Executive function will be assessed according to the validated Trails Making Task Part A and B	26 weeks
Memory	Episodic memory will be assessed according to the Wescher Memory Scale	26 weeks
Attention and Visual Reasoning	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	26 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle strength	Muscle strength in the participants will be assessed using a clinical dynamometer to measure grip strength	26 weeks
Physical function	Physical function will be assessed using the Timed up and Go measure	26 weeks
Systemic inflammation	Serum will be analysed for levels of specific cytokines	26 weeks
Change in Blood Level of Vitamin D (25-hydroxyvitamin D)	Serum will be analysed for change in levels from baseline	0, 12 and 26 weeks

Collaborators and Investigators

• Sponsor: University of Dublin, Trinity College
• Investigators: Principal Investigator: Maria O'Sullivan, PhD, The University of Dublin, Trinity College; Principal Investigator: Brian Lawlor, MD, The University of Dublin, Trinity College

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (ACTUAL): May 1, 2016
• Study Completion (ACTUAL): November 1, 2016

Study Registration Dates

• First Submitted: May 20, 2016
• First Submitted That Met QC Criteria: June 14, 2016
• First Posted (ESTIMATE): June 17, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): November 22, 2016
• Last Update Submitted That Met QC Criteria: November 21, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Dementia; Prevention; Cognitive function; Cholecalciferol; Physical function; Muscle mass; Vitamin D supplementation; Successful ageing
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Micronutrients; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol; Vitamins; Ergocalciferols
• Other Study ID Numbers: UniDublinTC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO