RCT of vitamin D in people with AACD (VitaMIND)
Research type
Research Study
Full title
A randomised clinical trial of vitamin D to improve cognition in people at risk of dementia (VitaMIND)
IRAS ID
247136
Contact name
Anne Corbett
Contact email
Sponsor organisation
University of Exeter
ISRCTN Number
ISRCTN79265514
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Research Summary
This study focuses on the major public health issue of dementia prevention. There is widespread consensus that development of treatments for older people who are at heightened risk of dementia is an urgent priority. There is a large body of evidence that supports the use of Vitamin D3 supplements to reduce risk and improve cognition, particularly in people who are deficient in vitamin D and already have subtle impairments in their cognition.
This study will deliver a large randomised controlled trial of vitamin D supplementation in 584 older adults with Age-Associated Cognitive Decline and risk of Vitamin D deficiency. The primary outcome will be impact on cognition at 24 months, using a validated online cognitive test battery. Additional data will be collected at 12 and 36 months. The trial will be managed through the online PROTECT platform (www.protectstudy.org.uk - further details in Section A6-2) to facilitate recruitment and retention. Compliance to the trial will be achieved through self-report and a sub-group of participants who will provide blood samples for Vitamin D testing.
This trial will provide novel data regarding the potential value of dietary supplementation with Vitamin D and whether this approach could improve the cognitive health of older adults across the UK.
Summary of Results
This trial aimed to determine whether taking Vitamin D supplements affected brain health in people with increased risk of dementia. Dementia is a devastating condition that affects nearly one million people in the UK. While new treatments are in the pipeline to treat the underlying causes of dementia there is a strong justification for seeking ways of reducing risk. There is also a more general need to provide older adults with ways to improve or maintain their brain health as they age.
Vitamin D deficiency is known to be linked to worse brain health but it was not clear whether taking supplements could improve brain function as a way of potentially reducing risk of dementia later in life. This is particularly of interest for people who have mild or moderate vitamin D deficiency since they are unlikely to be in contact with health services whereas severe deficiency is usually treated quickly due to its link with other health conditions.
This study therefore looked at whether daily vitamin D supplements had an effect on cognition in older adults with mild to moderate vitamin D deficiency.
The trial recruited 620 people aged 50 and over with mild to moderate vitamin D deficiency and concerns about their brain health. They were randomly allocated to receive either a daily dose of vitamin D tablets or a dummy tablet (placebo) for two years. They completed online measures of brain health using a computerised test system, in addition to questionnaires about their wellbeing and overall abilities. The trial was run on the PROTECT-UK online research platform.
The study showed that the Vitamin D supplements were safe, and the trial provided high quality data. However, analysis of data showed that the supplements did not lead to any improvements in brain health, wellbeing or the ability to carry out day-to-day tasks. This is an important finding as it shows that despite the importance of treating severe vitamin D deficiency, it may not be relevant to treat milder deficiencies as part of an overall approach to reduce risk of dementia.
The study also showed that clinical trials of low-risk treatments like supplements can be run very effectively using remote, online methods. This approach to research should be used more in the future to reduce the cost and duration of trials.REC name
Wales REC 3
REC reference
19/WA/0007
Date of REC Opinion
5 Mar 2019
REC opinion
Further Information Favourable Opinion