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Completed

NCT Number: NCT02804841

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

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.

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Key information

Conditions

Healthy Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Dublin, Trinity College

Dublin, Ireland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cholecalciferol -Vitamin D3

Dietary Supplement

Placebo -gel capsule containing no vitamin D.

Other

Primary outcomes

  1. Global Cognitive Function

    Time frame: 26 weeks

    Global cognitive function will be assessed using the validated Montreal Cognitive Assessment for all participants

  2. Executive Function

    Time frame: 26 weeks

    Executive function will be assessed according to the validated Trails Making Task Part A and B

  3. Memory

    Time frame: 26 weeks

    Episodic memory will be assessed according to the Wescher Memory Scale

  4. 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

Secondary outcomes

  1. Muscle strength

    Time frame: 26 weeks

    Muscle strength in the participants will be assessed using a clinical dynamometer to measure grip strength

  2. Physical function

    Time frame: 26 weeks

    Physical function will be assessed using the Timed up and Go measure

  3. Systemic inflammation

    Time frame: 26 weeks

    Serum will be analysed for levels of specific cytokines

  4. 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

Sponsors and collaborators

Lead sponsor

University of Dublin, Trinity College

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 17, 2016
Registry last updated
Nov 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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