Plain English Summary
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)
Trial website
Contact information
Type
Scientific
Primary contact
Dr Mark Farrar
ORCID ID
http://orcid.org/0000-0001-8602-7279
Contact details
Photobiology Unit
Salford Royal NHS Foundation Trust
Hope Hospital
Stott Lane
Salford
Manchester
M13 9PL
United Kingdom
Type
Public
Additional contact
Mrs Joanne Osman
ORCID ID
Contact details
Photobiology Unit
Salford Royal NHS Foundation Trust
Hope Hospital
Stott Lane
Salford
Manchester
M6 8HD
United Kingdom
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
19889
Study information
Scientific title
An experimental photodermatology study examining the impact of hands and face exposure on cutaneous vitamin D production
Acronym
Study hypothesis
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
University of Manchester Research Ethics Committee, 22/10/2015, ref: 15440
Study design
Non-randomised; Interventional; Design type: Prevention, Treatment
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 the contact details below to request a patient information sheet
Condition
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
Phase
Drug names
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 trial start date
20/04/2015
Overall trial end date
25/10/2016
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 40; UK Sample Size: 40
Participant 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
Recruitment start date
23/11/2015
Recruitment end date
31/03/2016
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Hope Hospital
Salford Royal NHS Foundation Trust
Photobiology Unit
Stott Lane
Salford
Manchester
M6 8HD
United Kingdom
Funders
Funder type
Charity
Funder name
British Skin Foundation
Alternative name(s)
BSF
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both publically funded and privately funded)
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Primary outcome data will be published once data have been validated and analysed.
Intention to publish date
31/03/2017
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list