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Can an app support a healthy vitamin D level in healthy volunteers?

Can an app support a healthy vitamin D level in healthy volunteers? The Sun4Health-Vitamin D randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN30217197
Enrollment
80
Registered
2021-05-07
Start date
2021-04-01
Completion date
Unknown
Last updated
2023-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Management of access to sunlight/amount of Vitamin D from sunlight in healthy volunteers Not Applicable

Interventions

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
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).

Sponsors

NHS Highland
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Between ages of 20 and 60 years

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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)

Countries

Scotland, United Kingdom

Contacts

Public ContactTatyana Brown
tatyana.brown@nhs.scot+44 (0)1463 255087

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026