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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02804841
Recruitment Status : Completed
First Posted : June 17, 2016
Last Update Posted : November 22, 2016
Sponsor:
Information provided by (Responsible Party):
Maria O'Sullivan, University of Dublin, Trinity College

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.


Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: Cholecalciferol -Vitamin D3 Other: Placebo -gel capsule containing no vitamin D. Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

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.



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


Locations
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Ireland
University of Dublin, Trinity College
Dublin, Ireland
Sponsors and Collaborators
University of Dublin, Trinity College
Investigators
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Principal Investigator: Maria O'Sullivan, PhD The University of Dublin, Trinity College
Principal Investigator: Brian Lawlor, MD The University of Dublin, Trinity College
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Responsible Party: Maria O'Sullivan, Associate Professor, University of Dublin, Trinity College
ClinicalTrials.gov Identifier: NCT02804841    
Other Study ID Numbers: UniDublinTC
First Posted: June 17, 2016    Key Record Dates
Last Update Posted: November 22, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Maria O'Sullivan, University of Dublin, Trinity College:
Vitamin D supplementation
Cognitive function
Physical function
Successful ageing
Prevention
Cholecalciferol
Dementia
Muscle mass
Additional relevant MeSH terms:
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Vitamin D
Ergocalciferols
Cholecalciferol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents