Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE May 20, 2016
First Posted Date  ICMJE June 17, 2016
Last Update Posted Date November 22, 2016
Study Start Date  ICMJE November 2015
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 14, 2016)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 14, 2016)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Vitamin D3 Supplementation on Cognitive Function in Community Dwelling Older Adults
Official Title  ICMJE D-activating Decline- Exploring the Effects of Vitamin D3 Supplementation on Cognitive Function in Community Dwelling Healthy Older Adults- A Pilot Study
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Healthy
Intervention  ICMJE
  • Dietary Supplement: Cholecalciferol -Vitamin D3
  • Other: Placebo -gel capsule containing no vitamin D.
Study Arms  ICMJE
  • Experimental: Intervention
    Healthy, Community Dwelling; Aged 60-80 years; Cholecalciferol -Vitamin D3, 4000 international units (IU) on alternating days.
    Intervention: 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.
    Intervention: Other: Placebo -gel capsule containing no vitamin D.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 14, 2016)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2016
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Ireland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02804841
Other Study ID Numbers  ICMJE UniDublinTC
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Maria O'Sullivan, University of Dublin, Trinity College
Study Sponsor  ICMJE University of Dublin, Trinity College
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Maria O'Sullivan, PhD The University of Dublin, Trinity College
Principal Investigator: Brian Lawlor, MD The University of Dublin, Trinity College
PRS Account University of Dublin, Trinity College
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP