Condition category
Skin and Connective Tissue Diseases
Date applied
12/05/2010
Date assigned
12/05/2010
Last edited
26/04/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Marie Durkin

ORCID ID

Contact details

Photobiology Unit
Dermatological Sciences
Hope Hospital
Stott Lane
Salford
M6 8HD
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

5625

Study information

Scientific title

Sun exposure levels for provision of vitamin D sufficiency in people of skin type V living in the UK

Acronym

Study hypothesis

1. What is the effect on vitamin D status in people of skin type V, of the amount of UV exposure recommended for white Caucasian subjects, and how much extra UV exposure do skin type V people require?

Intervention study:
A UV course will be given to 60 subjects in January/February, using a whole body cabinet with lamps emitting a UV spectrum similar to sunlight. Blood 25(OH)D levels measured weekly.

2. What levels of vitamin D are attained through natural sunlight exposure in skin type V individuals living in the UK? How do these relate to personal UV exposure doses? Does the relationship differ from that in white Caucasian individuals?

Observation study:
125 subjects will have blood 25(OH)D levels assessed once in each season, UV exposure measured through polysulphone badges and dietary vitamin D assessed through diet diaries.

The results of the experimental work in the intervention study can be related to the findings of the real population in the observation study. Moreover, both studies in skin type V volunteers can be related to the findings of the equivalent studies in the white Caucasian subjects.

Ethics approval

North Manchester Research Ethics Committee approved on the 20th May 2008 (ref: 08/H1006/24)

Study design

Single centre non-randomised prevention and treatment trial

Primary study design

Observational

Secondary study design

Single-centre

Trial setting

Hospitals

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: Skin; Subtopic: Skin (all Subtopics); Disease: Dermatology

Intervention

1. Intervention study:
1.1. Subjects were given simulated summer's sun exposures from a constant UVR dose via a full body cabinet, 3 times a week for 6 weeks. The subjects were split into 6 groups receiving either 0.65, 1.3 1.95, 2.6, 3.2, 3.9 SED. This was given in Jan/Feb, when there is no confounding ambient UVR
1.2. Vitamin D (25(OH)D) blood samples were taken pre-intervention and then weekly for 6 weeks
1.3. Patients completed diet diaries (1st week and 6th week) to assess dietary vitamin D

2. Observational study:
2.1. Vitamin D (25(OH)D) blood samples were taken in each season of the year (April - Spring, July - Summer, October - Autumn, January - Winter)
2.2. The subjects were also given polysulphone film badges to wear on their clothes for one week in each season to measure ambient UV
2.3. Sun exposure diaries were also used to give additional information about seasonal UV exposure
2.4. A diet diary was completed in each season for dietary vitamin D assessment.
Follow up was for one year.

The interventional follow up was for 7 weeks, the actual intervention (not treatment) was carried out over 6 weeks.

Intervention type

Supplement

Phase

Not Applicable

Drug names

Vitamin D

Primary outcome measures

1. Intervention study: % number of people reaching sufficient levels of vitamin D following simulated summer exposure
2. Observational study: the post summer vitamin D level required to maintain sufficiency throughout the winter months

Secondary outcome measures

Interventional study:
1. The % numbers reaching optimal levels of vitamin D following simulated summer sun exposure
2. Baseline winter levels of vitamin D deficiency, sufficiency and optimal levels

Overall trial start date

01/09/2008

Overall trial end date

30/05/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18 - 65 years old
2. South Asian descent
3. Male or female
4. Sun-reactive skin type V
5. Ambulant

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned sample size: 185

Participant exclusion criteria

1. History of skin cancer (intervention study)
2. History of a photosensitivity disorder (both)
3. Regular sunbathing/use of sunbeds (observational study)
4. Sunbathing/use of sunbeds in the past 3 months (intervention study)
5. Taking photoactive medication (interventional)
6. Pregnant or breast-feeding (interventional)

Recruitment start date

01/09/2008

Recruitment end date

30/05/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Photobiology Unit
Salford
M6 8HD
United Kingdom

Sponsor information

Organisation

University of Manchester (UK)

Sponsor details

c/o Mohammed Zubair
FMHS Research Office
3.53 Simon Building
University of Manchester
Manchester
M13 9PL
United Kingdom

Sponsor type

University/education

Website

http://www.manchester.ac.uk

Funders

Funder type

Charity

Funder name

Cancer Research UK (CRUK) (UK)

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21918215
2. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23615828

Publication citations

  1. Results

    Farrar MD, Kift R, Felton SJ, Berry JL, Durkin MT, Allan D, Vail A, Webb AR, Rhodes LE, Recommended summer sunlight exposure amounts fail to produce sufficient vitamin D status in UK adults of South Asian origin., Am. J. Clin. Nutr., 2011, 94, 5, 1219-1224, doi: 10.3945/ajcn.111.019976.

  2. Results

    Farrar MD, Webb AR, Kift R, Durkin MT, Allan D, Herbert A, Berry JL, Rhodes LE, Efficacy of a dose range of simulated sunlight exposures in raising vitamin D status in South Asian adults: implications for targeted guidance on sun exposure., Am. J. Clin. Nutr., 2013, 97, 6, 1210-1216, doi: 10.3945/ajcn.112.052639.

Additional files

Editorial Notes