Limited skin areas and vitamin D
| ISRCTN | ISRCTN91255549 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN91255549 |
| Secondary identifying numbers | 17553 |
- Submission date
- 04/02/2015
- Registration date
- 04/02/2015
- Last edited
- 08/02/2015
- 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 healthy bones. Calcium and phosphorus are essential for bone growth and also to strengthen bones and we need vitamin D to absorb these minerals. People get most of their vitamin D though exposure to sunlight. National guidance on requirements for vitamin D assume 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 more limited areas of skin can produce a sufficient rise in vitamin D levels to avoid deficiency.
Who can participate?
Healthy white Caucasian adults, aged between 20-60.
What does the study involve?
Volunteers undergo a six week course of simulated sunlight (ultraviolet light) exposures, wearing clothes that expose small areas of skin (hands and face).
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. We do not expect there to be any disadvantage from taking part. Participants may experience some redness of the skin for a short while after their sunburn threshold has been tested. 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 2014 to October 2017
Who is funding the study?
European Seventh Framework Programme (Belgium)
Who is the main contact?
Mrs Joanne Osman
Contact information
Scientific
Salford Royal NHS Foundation Trust
Photobiology Unit
Salford Royal Foundation Hospital
Stott Lane
Salford
Greater Manchester
M6 8HD
United Kingdom
Study information
| Study design | Non-randomised; Interventional; Design type: Not specified |
|---|---|
| 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 contact details to request a patient information sheet |
| Scientific title | An experimental photodermatology study to examine the ability of limited skin areas to produce vitamin D |
| Study objectives | The aim of this study is to determine if exposure of more limited areas of skin to simulated sunlight can produce a sufficient rise in vitamin D levels to avoid deficiency. |
| Ethics approval(s) | University of Manchester Research Ethics Committee, 14/10/2014, ref: 14335. |
| Health condition(s) or problem(s) studied | Topic: Dermatology; Subtopic: Skin (all Subtopics); Disease: Dermatology |
| Intervention | The intervention is solar-simulated ultraviolet radiation. A dose of 1.3 SED (standard erythema dose) is given three times a week for 6 weeks. There is no control arm. Blood samples are taken at the start of each week, before the first exposure, and one 3 days after the final exposure. Follow-up will then continue with blood samples after a further 2, 4 and 6 weeks. Total duration for treatment and follow-up = 12 weeks. |
| Intervention type | Other |
| Primary outcome measure | The primary outcome measure is serum 25-hydroxyvitamin D (25(OH)D) concentration which is measured at baseline, then weekly up to 6 weeks. Further samples to be taken at weeks 8, 10 and 12. Serum 25(OH)D is measured by liquid chromatography tandem mass spectrophotometry (LC-MS/MS). |
| Secondary outcome measures | N/A |
| Overall study start date | 01/11/2014 |
| Completion date | 31/10/2017 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned Sample Size: 60; UK Sample Size: 60 |
| Key inclusion criteria | 1. Healthy, ambulant, male and female adults aged 20-60 years 2. White Caucasian (sun-reactive skin type I-IV) 3. 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 3. Taking vitamin D, fish oil or calcium supplements 4. History of skin cancer or photosensitivity disorder 5. Pregnancy/lactation |
| Date of first enrolment | 01/11/2014 |
| Date of final enrolment | 31/10/2017 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Salford Royal Foundation Hospital
Stott Lane
Salford
Greater Manchester
M6 8HD
United Kingdom
Sponsor information
University/education
Oxford Road
Manchester
M13 9PL
England
United Kingdom
"ROR" |
https://ror.org/027m9bs27 |
|---|
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- EC Seventh Framework Programme, European Commission Seventh Framework Programme, EU Seventh Framework Programme, European Union Seventh Framework Programme, FP7
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
