Condition category
Skin and Connective Tissue Diseases
Date applied
04/02/2015
Date assigned
04/02/2015
Last edited
08/02/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Contact information

Type

Scientific

Primary contact

Mrs Joanne Osman

ORCID ID

Contact details

Salford Royal NHS Foundation Trust
Photobiology Unit
Salford Royal Foundation Hospital
Stott Lane
Salford
Greater Manchester
M6 8HD
United Kingdom

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

Sponsor information

Organisation

University of Manchester

Sponsor details

Oxford Road
Manchester
M13 9PL
United Kingdom

Sponsor type

University/education

Website

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

Belgium

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

Publication citations

Additional files

Editorial Notes