Plain English Summary
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
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
17553
Study information
Scientific title
An experimental photodermatology study to examine the ability of limited skin areas to produce vitamin D
Acronym
Study hypothesis
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
University of Manchester Research Ethics Committee, 14/10/2014, ref: 14335.
Study design
Non-randomised; Interventional; Design type: Not specified
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a patient information sheet
Condition
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
Phase
Drug names
Primary outcome measures
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 trial start date
01/11/2014
Overall trial end date
31/10/2017
Reason abandoned
Eligibility
Participant 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
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 60; UK Sample Size: 60
Participant 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
Recruitment start date
01/11/2014
Recruitment end date
31/10/2017
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Salford Royal NHS Foundation Trust
Photobiology Unit
Salford Royal Foundation Hospital
Stott Lane
Salford
Greater Manchester
M6 8HD
United Kingdom
Funders
Funder type
Government
Funder name
Seventh Framework Programme
Alternative name(s)
EC Seventh Framework Programme, European Commission Seventh Framework Programme, EU Seventh Framework Programme, European Union Seventh Framework Programme, FP7
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary