Hands and face exposure for vitamin D production
| ISRCTN | ISRCTN93416541 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN93416541 |
| Secondary identifying numbers | 19889 |
- Submission date
- 10/12/2015
- Registration date
- 10/12/2015
- Last edited
- 24/05/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Plain English summary of protocol
Background and study aims
Vitamin D is essential for good health, because it helps our bodies to absorb calcium from the diet. There is a lot of evidence that having enough vitamin D can help prevent against many diseases, such as heart disease, bone diseases and cancer. Although vitamins generally come from the diet, in the case of vitamin D, the majority of people actually get most of it from sunlight. National guidance on requirements for vitamin D assumes that casual exposure of limited areas of skin to summer sunlight is sufficient to avoid vitamin D deficiency. Previous studies have shown that a six week course of exposures to simulated summer sunlight while casually dressed (shorts and T-shirt) can produce adequate vitamin D levels in the majority of the UK white Caucasian population. The aim of this study is to determine if exposure of only hands and face can produce a sufficient rise in vitamin D levels to avoid deficiency.
Who can participate?
Healthy white Caucasian adults aged between 20 and 60.
What does the study involve?
All participants undergo a six week course of treatment, in which they are exposed to simulated sunlight (ultraviolet light) wearing clothes that expose only hands and face. Blood samples are taken at the start of the study, and then once a week so that the amount of vitamin D can be measured.
What are the possible benefits and risks of participating?
Participants will not benefit directly from taking part in this study, however if they are found to have vitamin D deficiency, their GP will be informed in order to offer advice and/or treatment. No notable risks are anticipated, however there may be slight discomfort and bruising following the blood sample.
Where is the study run from?
Salford Royal NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
November 2015 to October 2016
Who is funding the study?
The British Skin Foundation (UK)
Who is the main contact?
1. Dr Mark Farrar (scientific)
2. Mrs Joanne Osman (public)
Contact information
Scientific
Photobiology Unit
Salford Royal NHS Foundation Trust
Hope Hospital
Stott Lane
Salford
Manchester
M13 9PL
United Kingdom
 ORCID ID |
0000-0001-8602-7279 |
|---|
Public
Photobiology Unit
Salford Royal NHS Foundation Trust
Hope Hospital
Stott Lane
Salford
Manchester
M6 8HD
United Kingdom
Study information
| Study design | Non-randomised; Interventional; Design type: Prevention, Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | An experimental photodermatology study examining the impact of hands and face exposure on cutaneous vitamin D production |
| Study objectives | The aim of this study is to examine the change in vitamin D levels of white Caucasian adults during a course of simulated summer sunlight exposures to the hands and face. |
| Ethics approval(s) | University of Manchester Research Ethics Committee, 22/10/2015, ref: 15440 |
| Health condition(s) or problem(s) studied | Topic: Dermatology; Subtopic: Skin (all Subtopics); Disease: Dermatology |
| Intervention | All participants undergo the intervention involving solar-simulated ultraviolet radiation. A dose of 1.3 SED (standard erythema dose) is given three times a week for 6 weeks. Blood samples are taken at the start of each week, before the first exposure, and one 3 days after the final exposure. Total duration for treatment and follow-up is 6 weeks. |
| Intervention type | Other |
| Primary outcome measure | Serum 25-hydroxyvitamin D (25(OH)D) concentration is measured using liquid chromatography tandem mass spectrophotometry (LC-MS/MS) at baseline and then weekly for up to 6 weeks. |
| Secondary outcome measures | N/A |
| Overall study start date | 20/04/2015 |
| Completion date | 25/10/2016 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned Sample Size: 40; UK Sample Size: 40 |
| Total final enrolment | 44 |
| Key inclusion criteria | 1. Aged 20-60 years 2. Ambulant 3. Healthy 4. White Caucasian (sun-reactive skin type I-IV) 5. Willing and capable of participating to the extent and degree required by the protocol |
| Key exclusion criteria | 1. Sunbathing or sunbed use in the last 3 months 2. Taking photoactive medication or bone active therapies 3. Taking vitamin D, fish oil or calcium supplements 4. History of skin cancer or photosensitivity disorder 5. Pregnancy or lactation |
| Date of first enrolment | 23/11/2015 |
| Date of final enrolment | 31/03/2016 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Salford
M6 8HD
United Kingdom
Sponsor information
University/education
Oxford Road
Manchester
M13 9PL
England
United Kingdom
"ROR" |
https://ror.org/027m9bs27 |
|---|
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- BSF
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Primary outcome data will be published once data have been validated and analysed. |
| IPD sharing plan |
Editorial Notes
24/05/2021: The following changes have been made:
1. The final enrolment number has been added.
2. The trial participating centre has been changed from Hope Hospital to Salford Royal NHS Foundation Trust.
3. The intention to publish date has been changed from 31/03/2017 to 31/12/2021.
