Sun exposure for vitamin D sufficiency in skin type V

ISRCTN	ISRCTN07565297
DOI	https://doi.org/10.1186/ISRCTN07565297
Protocol serial number	5625
Sponsor	University of Manchester (UK)
Funder	Cancer Research UK (CRUK) (UK)

Submission date: 12/05/2010
Registration date: 12/05/2010
Last edited: 26/04/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Skin and Connective Tissue Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mrs Marie Durkin
Scientific

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

Study information

Primary study design	Observational
Study design	Single centre non-randomised prevention and treatment trial
Secondary study design	Single-centre
Study type	Participant information sheet
Scientific title	Sun exposure levels for provision of vitamin D sufficiency in people of skin type V living in the UK
Study objectives	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(s)	North Manchester Research Ethics Committee approved on the 20th May 2008 (ref: 08/H1006/24)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	30/05/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	185
Key inclusion criteria	1. Aged 18 - 65 years old 2. South Asian descent 3. Male or female 4. Sun-reactive skin type V 5. Ambulant
Key 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)
Date of first enrolment	01/09/2008
Date of final enrolment	30/05/2009

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Photobiology Unit

Salford
M6 8HD
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/11/2011		Yes	No
Results article	results	01/06/2013		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes