Vitamin D for people at risk of dementia
| ISRCTN | ISRCTN79265514 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN79265514 |
| IRAS number | 247136 |
| Secondary identifying numbers | 4, IRAS 247136 |
- Submission date
- 05/07/2018
- Registration date
- 23/07/2018
- Last edited
- 15/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
As we get older our brains also begin to age, resulting in a 'slowing down' of abilities such as memory or reasoning. These mental processes are collectively known as ‘cognition’. In some people, cognition declines further, leading to cognitive impairment or dementia, which affects 800,000 people in the UK. Therefore, dementia and cognitive decline are major public health issues, and there is increasingly a need to identify means of preventing or reducing the risk of dementia in order to improve the health of ageing populations worldwide. There is a growing body of evidence that indicates that people may be able to reduce their risk of dementia through certain lifestyle habits or activities. This is particularly true for people who are at higher risk due to their current cognitive abilities, lifestyle or overall health.
One promising avenue for reducing the risk of dementia is through dietary supplementation of Vitamin D. Vitamin D is produced by the body when exposed to sunlight during summer months and is available in some foods such as fish and eggs. However, a large proportion of older adults do not receive enough Vitamin D and few people take regular dietary supplements. Vitamin D is known to play an important role in brain health and cognition and may improve cognition and reduce the risk of dementia.
This study will provide vitamin D supplementation to people at risk of dementia, with the aim of determining whether this can reduce the risk of cognitive decline and dementia in older adults.
Who can participate?
People aged over 50 with dementia risk including those who have early changes in brain function (Age-Associated Cognitive Decline), a family history of dementia and/or subjective concerns about their cognitive health and are at risk of vitamin D deficiency in their diet.
What does the study involve?
Participants will be randomly allocated to receive either daily vitamin D supplements or a placebo (dummy pill). Pills will be taken daily for two years. Assessments will be completed at the beginning of the trial, after six months, one, and two years. The trial is being run using an online platform, meaning that registration, consent and all assessments will be completed online. Participants will log into a study portal, called the PROTECT study, and complete all study
tasks through their computer.
What are the possible benefits and risks of participating?
Participants in the treatment group may benefit from the dietary supplement through improvements to cognition if the trial is successful. All participants will be able to register for the national PROTECT cohort study as part of their involvement, which includes annual cognitive assessments and access to brain training games. There are no known risks to participants taking part in this study.
Where is the study run from?
University of Exeter (UK)
When is the study starting and how long is it expected to run for?
June 2018 to July 2023
Who is funding the study?
JP Moulton Foundation (UK)
Who is the main contact?
Mrs Ellie Pickering
e.pickering@exeter.ac.uk
Contact information
Scientific
University of Exeter Medical School
College House Room 1.23
St Luke’s Campus
Heavitree Road
Exeter
EX1 2LU
United Kingdom
| Phone | +44 01392 726046 |
|---|---|
| e.pickering@exeter.ac.uk |
Study information
| Study design | Interventional double-blind placebo-controlled two-arm single-centre randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | A randomised clinical trial of vitamin D to improve cognition in people at risk of dementia |
| Study acronym | VitaMIND |
| Study objectives | Current study hypothesis as of 23/04/2020: Vitamin D supplementation will confer a benefit to cognition in older adults with vitamin D deficiency and Age-Associated Cognitive Decline (AACD), subjective memory concerns and/or family history of dementia compared to placebo. _____ Previous study hypothesis: Vitamin D supplementation will confer a benefit to cognition in adults with AACD compared to placebo |
| Ethics approval(s) |
Approved 05/03/2019, Wales Research Ethics Committee 3 (Health and Care Research support Centre, Castlebridge 4, 15-19 Cowbridge Road East, Cardiff, CF11 9AB, United Kingdom; +44 (0)2920 785739; Wales.REC3@wales.nhs.uk), ref: 19/WA/0007 |
| Health condition(s) or problem(s) studied | Age-associated cognitive decline, subjective memory concerns and/or family history of dementia |
| Intervention | Current interventions as of 07/07/2023: Participants will be randomised into either the treatment or control arm of the study. Randomisation is achieved through simple randomisation delivered through REDCap Cloud following stratification for age, gender and level of estimated vitamin D deficiency. The active treatment arm will receive two-piece HPMC capsules containing Vitamin D3 (4000IU) produced by Healthspan as their product ‘Elite Vitamin D3’. Participants will receive one capsule daily, by oral administration, over two years. The control group will receive an identical placebo capsule with the same treatment regimen. Follow-up is conducted online through computerised assessment at baseline, 26, 52, and 104 weeks. Participants receive automated reminders to log into their study portal and complete all assessments. _____ Previous interventions as of 23/04/2020: Participants will be randomised into either the treatment or control arm of the study. Randomisation is achieved through simple randomisation delivered through REDCap Cloud following stratification for age, gender and level of estimated vitamin D deficiency. The active treatment arm will receive two-piece HPMC capsules containing Vitamin D3 (4000IU) produced by Healthspan as their product ‘Elite Vitamin D3’. Participants will receive one capsule daily, by oral administration, over three years. The control group will receive an identical placebo capsule with the same treatment regimen. Follow-up is conducted online through computerised assessment at baseline, 26, 52, 104 and 156 weeks. Participants receive automated reminders to log into their study portal and complete all assessments. _____ Previous interventions as of 23/07/2019: Participants will be randomised into either the treatment or control arm of the study. Randomisation is achieved through simple randomisation delivered through REDCap Cloud following stratification for age, gender, cognitive status and level of estimated vitamin D deficiency. The active treatment arm will receive two-piece HPMC capsules containing Vitamin D3 (4000IU) produced by Healthspan as their product ‘Elite Vitamin D3’. Participants will receive one capsule daily, by oral administration, over three years. The control group will receive an identical placebo capsule with the same treatment regimen. Follow-up is conducted online through computerised assessment at baseline, 26, 52, 104 and 156 weeks. Participants receive automated reminders to log into their study portal and complete all assessments. _____ Previous interventions: Participants will be randomised into either the treatment or control arm of the study. Randomisation is achieved through simple randomisation delivered through the online study portal (PROTECT), following stratification for age, gender and cognitive status. The active treatment arm will receive two-piece HPMC capsules containing Vitamin D3 (4000IU) produced by Healthspan as their product ‘Elite Vitamin D3’. Participants will receive one capsule daily, by oral administration, over three years. The control group will receive an identical placebo capsule with the same treatment regimen. Follow-up is conducted online through computerised assessment at baseline, 26, 52, 104 and 208 weeks. Participants receive automated reminders to log into their study portal and complete all assessments. |
| Intervention type | Supplement |
| Primary outcome measure | Current primary outcome measure as of 03/07/2023: Executive Function (Trails B) measured through online assessment using the PROTECT online test battery at baseline, 26, 52, and 104 weeks. This measure has been used to assess cognitive change in adults with dementia risk extensively in the literature (e.g. Park 2022, Kim et al 2021). Previous primary outcome measure as of 23/07/2019: Executive Function (Baddeley Grammatical Reasoning) measured through online assessment using the PROTECT online test battery at baseline, 26, 52, 104 and 156 weeks. This measure has been used to assess cognitive change in adults with AACD in a recent large online clinical trial (Corbett, et al. 2015a). Previous primary outcome measure: Executive Function (Baddeley Grammatical Reasoning) measured through online assessment using the validated cognitive assessment battery, CogTrack™, at baseline, 26, 52, 104 and 208 weeks |
| Secondary outcome measures | Current secondary outcome measures as of 03/07/2023: The following outcomes were measured at the baseline, 26, 52, and 104 weeks: 1. PROTECT Cognitive Test Battery (Paired Associate Learning, Digit Span, Self-Ordered Search Task [working / spatial memory tasks], Switching Stroop and Grammatical Reasoning [Executive Function Tasks]) 2. Instrumental Activities of Daily Living 3. EQ5D measure of health and wellbeing 4. Mild Behaviour Impairment Scale 5. Anonymous online survey to capture participant experience of the study Previous secondary outcome measures as of 23/07/2019: The following outcomes were measured at the baseline, 26, 52, 104 and 156 weeks: 1. Full PROTECT Cognitive Test Battery (Reaction time, Attentional Indices, Paired Associate Learning, Digit Span and Self-Ordered Search Task, Digit Vigilance, Verbal Learning, Spatial Working Memory, Executive Function) 2. Instrumental Activities of Daily Living 3. EQ5D measure of health and wellbeing 4. Mild Behaviour Impairment Scale Previous secondary outcome measures: The following outcomes were measured at the baseline, 26, 52, 104 and 208 weeks: 1. Full PROTECT Cognitive Test Battery (PROTECT test battery (Digit Vigilance, Verbal Learning, Spatial Working Memory, Executive Function) 2. Full CogTrack™ test Battery (Reaction time, Attentional Indices, Paired Associate Learning, Digit Span and Self-Ordered Search Task) 3. Instrumental Activities of Daily Living 4. EQ5D measure of health and wellbeing 5. Mild Behaviour Impairment Scale |
| Overall study start date | 01/06/2018 |
| Completion date | 31/07/2023 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Mixed |
| Lower age limit | 50 Years |
| Sex | Both |
| Target number of participants | 584 |
| Total final enrolment | 685 |
| Key inclusion criteria | Current inclusion criteria as of 23/04/2020: 1. Age 50 years and over 2. Already registered as a participant in the PROTECT study 3. Fulfilling research criteria for dementia risk: Either (1) Performing at least one Standard Deviation below age-matched population norms in two cognitive tests as measured using the validated PROTECT and online cognitive test battery; and/or (2) Reporting subjective memory concerns; and/or (3) Reported family history of dementia 4. Fulfilling criteria for vitamin D deficiency risk: Defined by a self-reported scale to be completed on registration. 5. Access to a computer and the internet. _____ Previous inclusion criteria: 1. Aged 50 years and over 2. Already registered as a participant on the PROTECT study 3. Fulfilling the AACD criteria: performing at least standard deviation below age-matched population norms in two cognitive tests, as measured using the validated PROTECT and CogTrackTM online cognitive test batteries 4. Fulfilling criteria for vitamin D deficiency risk (defined by a self-reported scale to be completed upon registration (based on Annweiler et al., 2017) 5. Access to a computer and the internet |
| Key exclusion criteria | 1. Diagnosed with dementia 2. Already participating in another active interventional clinical trial 3. Regularly taking any supplement containing vitamin D: 3.1. If the supplement is prescribed for a pre-existing condition, the participant will be excluded 3.2. If the supplement is bought over the counter, the participant will have the option of stopping the supplement and re-registering for the trial after a 28 day washout period 4. Prescribed the medication Digoxin (Lanoxin) |
| Date of first enrolment | 01/01/2019 |
| Date of final enrolment | 26/03/2021 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University of Exeter
Exeter
EX1 2LU
United Kingdom
Sponsor information
University/education
Research Ethics and Governance Office
Lafrowda House
St Germans Road
Exeter
EX4 6TL
England
United Kingdom
| Website | http://www.exeter.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/03yghzc09 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 31/01/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Academic publication in peer-reviewed journal Presentation at national / international conference Lay report including online content and social media Clinical report for primary care audience |
| IPD sharing plan | Current IPD sharing plan as of 03/07/2023: The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Anne Corbett (a.m.j.corbett@exeter.ac.uk) and Mrs Ellie Pickering (e.pickering@exeter.ac.uk). Fully anonymised study data will be available as composite cognitive scores and raw numerical scores for all other outcomes after the publication of the trial outcomes (expected July 2024) for three years. Data access will require a data access application submitted to the PROTECT steering committee, (protect.data@exeter.ac.uk) which is reviewed and approved on a case-by-case basis. Consent from participants will be collected to enable anonymised data sharing for approved collaborators. The steering committee retains the right to refuse the use of data in the event of a conflict with the overall PROTECT study core research. Previous IPD sharing plan: The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Anne Corbett (a.m.j.corbett@exeter.ac.uk) and Mrs Ellie Pickering (e.pickering@exeter.ac.uk). Fully anonymised study data will be available as composite cognitive scores and raw numerical scores for all other outcomes after publication of the trial outcomes (expected January 2023) for three years. Data access will require a data access application submitted to the PROTECT steering committee, which are reviewed and approved on a case-by-case basis. Consent from participants will be collected to enable anonymised data sharing for approved collaborators. The steering committee retains the right to refuse use of data in the event of conflict with overall PROTECT study core research. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Protocol file | version 8 | 05/05/2023 | 03/07/2023 | No | No |
| Basic results | 15/01/2025 | 15/01/2025 | No | No |
Additional files
Editorial Notes
15/01/2025: Basic results uploaded.
06/11/2024: The intention to publish date was changed from 31/10/2024 to 31/01/2025.
09/07/2024: The intention to publish date was changed from 31/07/2024 to 31/10/2024.
03/07/2023: The following changes have been made:
1. Uploaded protocol (not peer reviewed).
2. IRAS number added.
3. The overall study end date was changed from 31/10/2024 to 31/07/2023.
4. The interventions were changed.
5. The primary outcome measure was changed.
6. The secondary outcome measures were changed.
7. The recruitment end date was changed from 31/12/2020 to 26/03/2021.
8. The total final enrolment was added.
9. The individual participant data (IPD) sharing plan was updated.
10. The intention to publish date has been changed from 30/08/2025 to 31/07/2024.
11. The plain English summary was updated to reflect these changes.
11/12/2020: The following changes were made to the trial record:
1. The recruitment end date was changed from 18/01/2020 to 31/12/2020.
2. The overall end date was changed from 17/12/2024 to 31/10/2024.
3. The plain English summary was updated to reflect these changes.
24/11/2020: The following changes have been made:
1. The recruitment end date has been changed from 18/11/2020 to 18/01/2020.
2. The overall trial end date has been changed from 17/09/2024 to 17/12/2024.
3. The intention to publish date has been changed from 30/06/2025 to 30/08/2025.
18/09/2020: The following changes have been made:
1. The recruitment end date has been changed from 31/08/2020 to 18/11/2020.
2. The overall trial end date has been changed from 31/03/2024 to 17/09/2024.
3. The intention to publish date has been changed from 31/03/2024 to 30/06/2025.
23/04/2020: The following changes were made to the trial record:
1. The hypothesis was changed.
2. The overall end date was changed from 31/03/2023 to 31/03/2024.
3. The condition was changed from "Age-associated cognitive decline" to "Age-associated cognitive decline, subjective memory concerns and/or family history of dementia".
4. The interventions were changed.
5. The inclusion criteria were changed.
6. The recruitment end date was changed from 31/03/2020 to 31/08/2020.
7. The plain English summary was updated to reflect these changes.
09/04/2020: The scientific contact has been updated.
04/11/2019: The following changes were made:
1. The recruitment end date has been changed from 31/10/2019 to 31/03/2020.
2. The overall trial end date has been changed from 31/10/2022 to 31/03/2023.
3. The intention to publish date has been changed from 31/10/2023 to 31/03/2024.
23/07/2019: The ethics approval, interventions, primary and secondary outcome measures were updated.
22/07/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/04/2019 to 31/10/2019.
2. The overall trial end date was changed from 01/02/2022 to 31/10/2022.
3. The intention to publish date was changed from 01/01/2022 to 31/10/2023.
