Can an app support a healthy vitamin D level in healthy volunteers?
| ISRCTN | ISRCTN30217197 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN30217197 |
| Secondary identifying numbers | V4.2 |
- Submission date
- 16/04/2021
- Registration date
- 07/05/2021
- Last edited
- 02/12/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English Summary
Background and study aims
This small scale pilot trial seeks to determine whether the app Sun4Health (provided by siHealth Ltd) can be effective in supporting its users to maintain a ‘healthy’ vitamin D level whilst making sure they manage a safe level of exposure to the sun.
Who can participate?
Healthy volunteers aged between 20 and 60
What does the study involve?
Participation will involve the use of an app that will model vitamin D blood level by satellite-based monitoring of their sun exposure, then providing recommendations for supporting better health. It will require participants to use the app on a smartphone connected to the internet and with GPS localization active; regularly check if the app correctly detects if they are indoors or outdoors (adjusting when needed); set in the app their sunscreen use and clothes (e.g. summer wear, winter wear) throughout the day; provide diary data through the app (e.g. food and supplements intake). In addition, participants will be asked to provide a regular monthly or fortnightly blood spot test for vitamin D (D3 and D2).
What are the potential benefits and risks of participating?
The potential benefits are learning more about personal management of exposure to sunlight whilst obtaining maximum benefit of Vitamin D from that sunlight. The only risk is doing the finger prick blood spot on a regular basis - this may involve a very low level of pain.
Where is the study run from?
NHS Highland (UK)
When is the study starting and how long is it expected to run for?
August 2020 to January 2022
Who is funding the study?
siHealth Ltd (UK)
Who is the main contact?
Ms Tatyana Brown
tatyana.brown@nhs.scot
Dr Rowan Temple
technology.innovation@sihealth.co.uk
Contact information
Public
RDI Division
Centre for Health Science
Old Perth Road
Inverness
IV2 3JH
United Kingdom
| Phone | +44 (0)1463 255087 |
|---|---|
| tatyana.brown@nhs.scot |
Scientific
siHealth Ltd
Didcot
OX11 0QX
United Kingdom
| Phone | +44 1865 589309 |
|---|---|
| technology.innovation@sihealth.co.uk |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Can an app support a healthy vitamin D level in healthy volunteers? The Sun4Health-Vitamin D randomized controlled trial |
| Study acronym | VitD App |
| Study hypothesis | The aim of this pilot study is to identify and evaluate the effects on healthy volunteers of an app designed to provide information and recommendations to improve the health of individuals in relation to vitamin D. |
| Ethics approval(s) | This study does not require ethics approval. The researchers have checked with the NHS REC and as it is a healthy volunteer study it was judged to not require REC approval. Approved 31/03/2021, NHS Highland Research, Development & Innovation Office (NHS Highland RD&I Office, Centre for Health Science, Old Perth Road, Inverness, IV2 3JH, UK; Tel: not provided; beth.sage@nhs.scot), ref: HIGHLAND 1737 |
| Condition | Management of access to sunlight/amount of Vitamin D from sunlight in healthy volunteers |
| Intervention | Randomisation is carried out following the recruitment of the participants and stratification of skin phototype. Randomisation is a simple 1:1, using Excel. Participation will involve the use of an app that will model vitamin D blood level by satellite-based monitoring of their sun exposure, then providing recommendations for supporting better health. It will require participants to use the app on a smartphone connected to the internet and with GPS localization active; regularly check if the app correctly detects if they are indoor or outdoor (adjusting when needed); set in the app their sunscreen use and clothes (e.g. summer wear, winter wear) throughout the day; provide diary data through the app (e.g. food and supplements intake). In addition, participants will be asked to provide a regular monthly or fortnightly blood spot test for vitamin D (D3 and D2). The control group receives access to the Sun4Health app with a diary but no access to the Sun4Health information and recommendations about sun exposure. All participants are expected to use the app for 8 months in total. The study will be completed at the end of month 9. |
| Intervention type | Behavioural |
| Primary outcome measure | Accuracy of the siHealth proprietary model for vitamin D levels in the blood using data collected from the app through its use by participants. Vitamin D2 and 3 levels are measured using blood spot samples at baseline (T0), T0 + 1 month, T0 + 1 months and 15 days, T0 + 2 months, T0 + 2 months and 15 days, T0 + 3 months, T0 + 3 months and 15 days, T0 + 4 months, T0 + 5 months, T0 + 6 months, T0 + 7 months, T0 + 8 months (final) |
| Secondary outcome measures | Food intake, satisfaction with use of the app, deviations in data entered (e.g. inaccurate exposure times, inaccurate supplement recording) and any adverse events related to sun exposure (e.g. sunburn) measured using a fortnightly app-based questionnaire for the duration of the study (8 months) |
| Overall study start date | 10/08/2020 |
| Overall study end date | 31/01/2022 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 80 |
| Total final enrolment | 106 |
| Participant inclusion criteria | Between ages of 20 and 60 years |
| Participant exclusion criteria | 1. Under 20 years old 2. Over 60 years old 3. Unable to provide written informed consent or not able to understand the Participant Information Sheet 4. Vulnerable people deemed inappropriate to approach e.g. children or prisoners 5. Persons who have been told by a clinician that medication they are currently taking may increase the risk of photosensitivity 6. People with a previous or current medical history of skin cancer as exposure to the sun is of greater risk in this population. 7. People who are undergoing medical phototherapy 8. People who are pregnant 9. People who report that they have the following conditions: Crohn’s disease, cystic fibrosis, celiac disease 10. People who use sunbeds more than once every 6 months on average 11. Not owning a smartphone suitable for accessing the app |
| Recruitment start date | 01/04/2021 |
| Recruitment end date | 31/05/2021 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
Beechwood Park
Old Perth Road
Inverness
IV2 3BW
United Kingdom
Sponsor information
Hospital/treatment centre
Assynt House
Beechwood Park
Old Perth Road
Inverness
IV2 3BW
Scotland
United Kingdom
| Phone | +44 (0)1463 255912 |
|---|---|
| frances.hines@nhs.scot | |
| Website | https://www.nhshighland.scot.nhs.uk/ |
"ROR" |
https://ror.org/010ypq317 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/04/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | At the current time the funder does not want the protocol to be made available for commercially confidentiality reasons. There is an Agreement between the funder and NHS Highland to cover all aspects including publications. siHealth Ltd will be responsible for the majority of publications in relation to the evaluation of their Sun4Health App, and NHS Highland will develop two publications with permission from siHealth looking at the challenges of remote delivery of research studies and general use of apps for preventative health management. |
| IPD sharing plan | As this pilot trial is being undertaken for a commercial organisation to evaluate their product (App) they currently do not want to make this dataset available. However, they may consider this more appropriate at the end of the trial. |
Editorial Notes
02/12/2022: The following changes were made to the trial record:
1. The total final enrolment wad added.
2. A scientific contact was added.
3. The intention to publish date was changed from 05/12/2022 to 01/04/2023.
16/04/2021: Trial's existence confirmed by the NHS Highland Research, Development & Innovation Office.
