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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02804841
• Other study ID #: UniDublinTC
• Status: Completed
• Phase: N/A
• First received: May 20, 2016
• Last updated: November 21, 2016
• Start date: November 2015
• Est. completion date: November 2016

Study information

• Verified date: November 2016
• Source: University of Dublin, Trinity College
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ireland: Health Products Regulatory Authority
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• Cholecalciferol -Vitamin D3

Other:
• Placebo -gel capsule containing no vitamin D.

Locations

Country	Name	City	State
Ireland	University of Dublin, Trinity College	Dublin

Sponsors (1)

Lead Sponsor	Collaborator
University of Dublin, Trinity College

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global Cognitive Function	Global cognitive function will be assessed using the validated Montreal Cognitive Assessment for all participants	26 weeks	No
Primary	Executive Function	Executive function will be assessed according to the validated Trails Making Task Part A and B	26 weeks	No
Primary	Memory	Episodic memory will be assessed according to the Wescher Memory Scale	26 weeks	No
Primary	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	No
Secondary	Muscle strength	Muscle strength in the participants will be assessed using a clinical dynamometer to measure grip strength	26 weeks	No
Secondary	Physical function	Physical function will be assessed using the Timed up and Go measure	26 weeks	No
Secondary	Systemic inflammation	Serum will be analysed for levels of specific cytokines	26 weeks	No
Secondary	Change in Blood Level of Vitamin D (25-hydroxyvitamin D)	Serum will be analysed for change in levels from baseline	0, 12 and 26 weeks	No