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The Effect of Omega-3 Polyunsaturated Fatty Acids on UV-induced Immunosuppression


N/A
18 Years
N/A
Not Enrolling
Female
Skin Cancer

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Trial Information

The Effect of Omega-3 Polyunsaturated Fatty Acids on UV-induced Immunosuppression


Skin cancer is one of the most common human cancers with a rising incidence and considerable
negative impact on human health. Exposure to ultraviolet radiation (UVR) in sunlight is the
major aetiological factor in skin cancer initiation and progression. Human case-control
studies have reported an inverse relationship between dietary fish or omega-3
polyunsaturated fatty acid (PUFA) intake and occurrence of non-melanoma skin cancer. Omega-3
PUFA have the potential to reduce the risk of photocarcinogenesis primarily by their ability
to reduce production of prostaglandin E2 and consequently photoimmunosuppression. To date,
no studies have assessed the impact of omega-3 PUFA on skin photoimmunosuppression in
humans.

OBJECTIVE: To examine the potential of dietary omega-3 PUFA to protect against UVR-induced
cutaneous immunosuppression in humans.

STUDY DESIGN: A double-blind randomised controlled nutritional study in 64 healthy human
volunteers with nickel sensitivity. Volunteers will receive 3 months dietary supplementation
with either omega-3 PUFA (n=32) or gelatine (n=32) both provided in identical gelatine
capsules.

The aim is to quantify the influence of omega-3 PUFA on:

1. UVR-induced suppression of clinical contact hypersensitivity (CHS) responses

2. UVR-induced modulation of epidermal Langerhans cell trafficking

3. UVR-induced modulation of levels of immunoregulatory mediators


Inclusion Criteria:



- Pre-menopausal females

- Sun-reactive skin type I / II

- Reporting allergy to jewellery with nickel content

Exclusion Criteria:

- 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

Degree of suppression of nickel-induced contact hypersensitivity

Outcome Description:

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

Outcome Time Frame:

3 months

Safety Issue:

No

Principal Investigator

Lesley E Rhodes, MBBS, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Manchester

Authority:

United Kingdom: Research Ethics Committee

Study ID:

AICR 08-0131

NCT ID:

NCT01032343

Start Date:

July 2008

Completion Date:

November 2010

Related Keywords:

  • Skin Cancer
  • Immunosuppression
  • Ultraviolet radiation
  • Nickel
  • Contact hypersensitivity
  • Skin Neoplasms

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