Sun exposure for vitamin D sufficiency in skin type V
ISRCTN | ISRCTN07565297 |
---|---|
DOI | https://doi.org/10.1186/ISRCTN07565297 |
Secondary identifying numbers | 5625 |
- 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
Scientific
Photobiology Unit
Dermatological Sciences
Hope Hospital
Stott Lane
Salford
M6 8HD
United Kingdom
Study information
Study design | Single centre non-randomised prevention and treatment trial |
---|---|
Primary study design | Observational |
Secondary study design | Single-centre |
Study setting(s) | Hospital |
Study type | Treatment |
Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 01/09/2008 |
Completion date | 30/05/2009 |
Eligibility
Participant type(s) | Patient |
---|---|
Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | Planned sample size: 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
- England
- United Kingdom
Study participating centre
Photobiology Unit
Salford
M6 8HD
United Kingdom
M6 8HD
United Kingdom
Sponsor information
University of Manchester (UK)
University/education
University/education
c/o Mohammed Zubair
FMHS Research Office
3.53 Simon Building
University of Manchester
Manchester
M13 9PL
England
United Kingdom
Website | http://www.manchester.ac.uk |
---|---|
https://ror.org/027m9bs27 |
Funders
Funder type
Charity
Cancer Research UK (CRUK) (UK)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
Results and Publications
Intention to publish date | |
---|---|
Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
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 |