None listed
Conditions
Brief summary
The primary aim of this 18-month randomised, double-blind, placebo-controlled clinical trial is to establish whether vitamin D supplementation can delay progression of cognitive decline amongst older adults with Mild Cognitive Impairment (MCI) who have low vitamin D concentrations (between 12.5 and 50 nmol/L). The main hypothesis of this study is that older adults with MCI randomised to a 18-month treatment with vitamin D will experience significantly less cognitive decline (as measured with the CAMCOG) at the end of the 18-months follow-up than subjects with MCI randomised to placebo. Secondary outcomes of interest for this study include quality of life, gait, balance and muscle strength.
Interventions
18-month trial of 1000 IU Vitamin D daily by oral tablet.
Sponsors
Professor Nicola Lautenschlager
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adults with mild cognitive impairment (-1.5 standard deviations below norm on any task in the Consortium to Establish a Registry for Alzheimer’s Disease (CERAD) neuropsychological battery), over 65 years of age, Vitamin D concentration between 12.5 and 50 nmol/L at baseline.
Exclusion criteria
Diagnosis of osteoporosis requiring treatment, no informant available, severe physical or medical illness that would preclude completion of the trial, hearing or visual impairment that would preclude assessments, already in an intervention trial, clinical history of stroke, fall in the last 3 months, heart attack in the last 3 months, fall with fracture over the age of 65, history of kidney or bladder stones, current acute depression, history of schizophrenia, current diagnosis of dementia.
Outcome results
None listed