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

NCT ID: NCT02804841

Last Updated: 2016-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2016-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Keywords

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Vitamin D supplementation Cognitive function Physical function Successful ageing Prevention Cholecalciferol Dementia Muscle mass

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Intervention

Healthy, Community Dwelling; Aged 60-80 years; Cholecalciferol -Vitamin D3, 4000 international units (IU) on alternating days.

Group Type EXPERIMENTAL

Cholecalciferol -Vitamin D3

Intervention Type DIETARY_SUPPLEMENT

Placebo

Healthy, Community Dwelling; Aged 60-80 years; Placebo -gel capsule containing no vitamin D on alternating days.

Group Type PLACEBO_COMPARATOR

Placebo -gel capsule containing no vitamin D.

Intervention Type OTHER

Interventions

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Cholecalciferol -Vitamin D3

Intervention Type DIETARY_SUPPLEMENT

Placebo -gel capsule containing no vitamin D.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Dublin, Trinity College

OTHER

Sponsor Role lead

Responsible Party

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Maria O'Sullivan

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maria O'Sullivan, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Dublin, Trinity College

Brian Lawlor, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Dublin, Trinity College

Locations

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University of Dublin, Trinity College

Dublin, , Ireland

Site Status

Countries

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Ireland

Other Identifiers

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UniDublinTC

Identifier Type: -

Identifier Source: org_study_id