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Sun exposure for vitamin D sufficiency in skin type V
ISRCTN ISRCTN07565297
DOI 10.1186/ISRCTN07565297
ClinicalTrials.gov identifier
EudraCT number
Public title Sun exposure for vitamin D sufficiency in skin type V
Scientific title Sun exposure levels for provision of vitamin D sufficiency in people of skin type V living in the UK
Acronym N/A
Serial number at source 5625
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.
Lay summary Not provided at time of registration
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
Countries of recruitment United Kingdom
Disease/condition/study domain Topic: Skin; Subtopic: Skin (all Subtopics); Disease: Dermatology
Participants - inclusion criteria 1. Aged 18 - 65 years old
2. South Asian descent
3. Male or female
4. Sun-reactive skin type V
5. Ambulant
Participants - 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)
Anticipated start date 01/09/2008
Anticipated end date 30/05/2009
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants Planned sample size: 185
Interventions 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.
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
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
Sources of funding Cancer Research UK (CRUK) (UK)
Trial website
Publications 1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21918215
2. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23615828
Contact name Mrs  Marie  Durkin
  Address Photobiology Unit
Dermatological Sciences
Hope Hospital
Stott Lane
  City/town Salford
  Zip/Postcode M6 8HD
  Country United Kingdom
Sponsor University of Manchester (UK)
  Address c/o Mohammed Zubair
FMHS Research Office
3.53 Simon Building
University of Manchester
  City/town Manchester
  Zip/Postcode M13 9PL
  Country United Kingdom
  Sponsor website: http://www.manchester.ac.uk
Date applied 12/05/2010
Last edited 26/04/2013
Date ISRCTN assigned 12/05/2010
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