Condition category
Skin and Connective Tissue Diseases
Date applied
10/12/2015
Date assigned
10/12/2015
Last edited
14/12/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

Sponsor information

Organisation

University of Manchester

Sponsor details

Oxford Road
Manchester
M13 9PL
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

British Skin Foundation

Alternative name(s)

BSF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes