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

NCT02804841 | Completed DMC

• 1 other identifier: UniDublinTC
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Muscle strength

  26 weeks

• Physical function

  26 weeks

• Systemic inflammation

  26 weeks

• Change in Blood Level of Vitamin D (25-hydroxyvitamin D)

  0, 12 and 26 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

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

Dietary Supplement: Cholecalciferol -Vitamin D3

Placebo

PLACEBO COMPARATOR

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.

Interventions

Cholecalciferol -Vitamin D3 DIETARY_SUPPLEMENT

Intervention

Placebo -gel capsule containing no vitamin D. OTHER

Placebo

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Community Dwelling healthy volunteers
• Ability to provide written consent.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Dublin, Trinity College: lead

Study Sites (1)

University of Dublin, Trinity College

Dublin, Ireland

Location

MeSH Terms

Conditions

Dementia

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Maria O'Sullivan, PhD

  The University of Dublin, Trinity College

  PRINCIPAL INVESTIGATOR

• Brian Lawlor, MD

  The University of Dublin, Trinity College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 20, 2016
• First Posted: June 17, 2016
• Study Start: November 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: November 1, 2016
• Last Updated: November 22, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)