Plain English Summary
Not provided at time of registration
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT01032343
Protocol/serial number
N/A
Study information
Scientific title
Oral omega-3 polyunsaturated fatty acid (n-3 PUFA) supplementation in ultraviolet radiation (UVR) induced cutaneous immunosuppression: a single site, double-blind, randomised, placebo controlled nutritional study
Acronym
Study hypothesis
Exposure to ultraviolet radiation (UVR) is a major cause of skin cancer development and acts to initiate cancer as well as promoting tumour development through photo-immunosuppression. Protection against photo-immunosuppression of contact hypersensitivity (CHS) in experimental models has been shown to correlate with protection against photocarcinogenesis.
Experimental models show that photo-immunosuppression, and consequently photocarcinogenesis, is reduced by dietary intervention with omega-3 polyunsaturated fatty acid (n-3 PUFA). However, this has not been directly explored in humans. Positive results from this study would lead to further research examining the influence of n-3 PUFA on skin cancer occurrence.
We hypothesise that oral n-3 PUFA supplements will protect against UVR induced cutaneous immunosuppression in humans.
Ethics approval
North Manchester Research Ethics Committee gave approval on the 13th June 2008 (ref: 08/H1006/30)
Study design
Single centre, double-blind, randomised, placebo controlled nutritional study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
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
Skin cancer prevention
Intervention
Active: fish oil supplements rich in n-3 PUFAs (Incromega E7010 SR, Croda, UK); 5 x 1 g capsules to be taken with breakfast
Control (placebo): medium chain triglyceride oil (GTCC, Croda, UK); 5 x 1 g capsules to be taken with breakfast
For each volunteer, the duration of nutritional supplementation is 12 weeks; follow-up is 2 weeks.
Intervention type
Supplement
Phase
Not Applicable
Drug names
Omega-3 polyunsaturated fatty acid (n-3 PUFA) supplementation
Primary outcome measure
To examine the protective effect of n-3 PUFA on:
1. UVR-induced suppression of clinical CHS responses using the International Contact Dermatitis Research Group (ICDRG) grading scale: No reaction (-) to extreme positive (+++)
2. UVR-induced modulation of immune cells (epidermal Langerhans cells) using immunohistochemistry of epidermal sheets
Assessed simultaneously at 13 weeks.
Secondary outcome measures
Levels of immunoregulatory mediators in the skin using mass spectrometry analysis and Luminex analysis of cytokine expression in suction blister fluid. Assessed simultaneously at 13 weeks.
Overall trial start date
02/03/2009
Overall trial end date
31/08/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Female
2. Aged 18 - 60 years
3. Sun reactive skin type 1 or 2
4. Reporting allergy to jewellery with nickel content
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
64
Participant exclusion criteria
1. History of atopy
2. History of skin cancer
3. History of a photosensitivity disorder
4. Sunbathing in the past 3 months
5. Pregnancy
6. History of cardiac disease
7. Taking of photoactive medication
8. Not able to eat fish or gelatin
9. Taking fish oil supplements prior to the study
10. Consuming more than 3 meals containing oily fish per week
Recruitment start date
02/03/2009
Recruitment end date
31/08/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Photobiology Unit
Manchester
M6 8HD
United Kingdom
Sponsor information
Organisation
University of Manchester (UK)
Sponsor details
c/o Karen Shaw
Head of Research Office
Christie Building
Oxford Road
Manchester
M13 9PL
United Kingdom
+44 (0)161 275 8795
karen.shaw@manchester.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Association for International Cancer Research (AICR) (UK) (ref: 08-0131)
Alternative name(s)
AICR
Funding Body Type
private sector organisation
Funding Body Subtype
International organizations
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Planned publication in a nutrition journal.
Intention to publish date
31/03/2013
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2013 results in: https://www.ncbi.nlm.nih.gov/pubmed/23364005
2014 results in: https://www.ncbi.nlm.nih.gov/pubmed/24311515