NCT01032343

Brief Summary

Skin cancer incidence continues to rise and ultraviolet radiation (UVR) in sunlight is the principal cause. Solar UVR can promote cancer development through its ability to suppress the immune system. The purpose of this study is to determine whether dietary supplementation with omega-3 polyunsaturated fatty acids can protect human skin from UVR-induced immunosuppression.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

December 14, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 15, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

August 22, 2013

Status Verified

August 1, 2013

Enrollment Period

2 years

First QC Date

December 14, 2009

Last Update Submit

August 21, 2013

Conditions

Skin Cancer

Keywords

ImmunosuppressionUltraviolet radiationNickelContact hypersensitivity

Outcome Measures

Primary Outcomes (1)

  • Degree of suppression of nickel-induced contact hypersensitivity

    Measurement of the erythema of nickel-induced eczema using a reflectance instrument

    3 months

Secondary Outcomes (3)

  • Intergroup comparison of cytokine and eicosanoid levels and Langerhans cell numbers

    3 months

  • Correlation of susceptibility to photoimmunosuppression in all subjects with their erythrocyte omega-3:omega-6 PUFA ratio

    3 months

  • Correlation of susceptibility to photoimmunosuppression with cytokine and eicosanoid levels and Langerhans cell numbers

    3 months

Study Arms (2)

Omega-3 PUFA capsule

ACTIVE COMPARATOR
Dietary Supplement: Omega-3 PUFA

Gelatine capsule

PLACEBO COMPARATOR
Dietary Supplement: Gelatine

Interventions

Omega-3 PUFADIETARY_SUPPLEMENT

One capsule (4g omega-3 PUFA) daily for 3 months

Omega-3 PUFA capsule
GelatineDIETARY_SUPPLEMENT

One capsule daily for 3 months

Gelatine capsule

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pre-menopausal females
  • Sun-reactive skin type I / II
  • Reporting allergy to jewellery with nickel content

You may not qualify if:

  • History of atopy
  • History of skin cancer
  • History of a photosensitivity disorder
  • Sunbathing (including sunbeds) in the last 3 months
  • Pregnancy
  • History of cardiac disease
  • Taking photoactive medicine
  • Not able to eat fish or gelatine
  • Taking fish oil supplements prior to the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Salford Royal NHS Foundation Trust

Manchester, M6 8HD, United Kingdom

Location

Related Publications (2)

  • Pilkington SM, Massey KA, Bennett SP, Al-Aasswad NM, Roshdy K, Gibbs NK, Friedmann PS, Nicolaou A, Rhodes LE. Randomized controlled trial of oral omega-3 PUFA in solar-simulated radiation-induced suppression of human cutaneous immune responses. Am J Clin Nutr. 2013 Mar;97(3):646-52. doi: 10.3945/ajcn.112.049494. Epub 2013 Jan 30.

    PMID: 23364005RESULT

  • Pilkington SM, Rhodes LE, Al-Aasswad NM, Massey KA, Nicolaou A. Impact of EPA ingestion on COX- and LOX-mediated eicosanoid synthesis in skin with and without a pro-inflammatory UVR challenge--report of a randomised controlled study in humans. Mol Nutr Food Res. 2014 Mar;58(3):580-90. doi: 10.1002/mnfr.201300405. Epub 2013 Dec 5.

    PMID: 24311515DERIVED

Related Links

MeSH Terms

Conditions

Skin NeoplasmsDermatitis, Contact

Interventions

Docosahexaenoic AcidsGelatin

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsSkin DiseasesSkin and Connective Tissue DiseasesDermatitisSkin Diseases, Eczematous

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOilsScleroproteinsProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Lesley E Rhodes, MBBS, MD

    University of Manchester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Experimental Dermatology

Study Record Dates

First Submitted

December 14, 2009

First Posted

December 15, 2009

Study Start

July 1, 2008

Primary Completion

July 1, 2010

Study Completion

November 1, 2010

Last Updated

August 22, 2013

Record last verified: 2013-08

Locations

GB(1)