Overview

This trial has been completed.

Condition healthy
Treatments cholecalciferol -vitamin d3, placebo -gel capsule containing no vitamin d.
Sponsor University of Dublin, Trinity College
Start date November 2015
End date May 2016
Trial size 60 participants
Trial identifier NCT02804841, UniDublinTC

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose prevention
Arm
(Experimental)
Healthy, Community Dwelling; Aged 60-80 years; Cholecalciferol -Vitamin D3, 4000 international units (IU) on alternating days.
cholecalciferol -vitamin d3
(Placebo Comparator)
Healthy, Community Dwelling; Aged 60-80 years; Placebo -gel capsule containing no vitamin D on alternating days.
placebo -gel capsule containing no vitamin d.

Primary Outcomes

Measure
Global Cognitive Function
time frame: 26 weeks
Executive Function
time frame: 26 weeks
Memory
time frame: 26 weeks
Attention and Visual Reasoning
time frame: 26 weeks

Secondary Outcomes

Measure
Muscle strength
time frame: 26 weeks
Physical function
time frame: 26 weeks
Systemic inflammation
time frame: 26 weeks
Change in Blood Level of Vitamin D (25-hydroxyvitamin D)
time frame: 0, 12 and 26 weeks

Eligibility Criteria

Male or female participants from 60 years up to 80 years old.

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

Additional Information

Official title D-activating Decline- Exploring the Effects of Vitamin D3 Supplementation on Cognitive Function in Community Dwelling Healthy Older Adults- A Pilot Study
Principal investigator Maria O'Sullivan, PhD
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by University of Dublin, Trinity College.