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NCT00685438 Clinical Trial

Ultraviolet Exposure, Antioxidant Use and Skin Erythema at Extreme High Altitude

Oxidative Stress Clinical Trial

Official title:
Observational Study of Skin Erythema by Spectrophotometer, and UV Exposure With Viospore Ultraviolet Monitors at Extreme Altitude (Mt. Everest, North Side)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00685438
Other study ID # 005-2007
Secondary ID
Status Completed
Phase N/A
First received May 22, 2008
Last updated May 27, 2008
Start date April 2007
Est. completion date June 2007

Study information
Verified date May 2008
Source Sunnybrook Health Sciences Centre
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Observational

Clinical Trial Summary

With the increasing tourism and adventure travel into extreme environments comes the need to reassess the required protection against ultraviolet (UV) radiation and possible other oxidative stresses. This is an observational study of UV radiation exposure and skin erythema while at extreme altitude (Mt. Everest). In addition to UV exposure, skin erythema, antioxidant use (such as vitamins C and E) will be measured.

Hypothesis:

1. UV radiation at extreme altitude has larger effects on the skin than at sea level; therefore requiring an adjustment of the antioxidant use for adequate protection.

2. The skin is an accurate reflection of UV and oxidative stress exposure

3. The efficacy of oxidatives stress is reflective of the ethnicity of the individual.

Description:

The literature widely acknowledges the deleterious effects of UV radiation on skin health, via production of oxidative free radicals. Consequently, there have been numerous studies on the potential dermatological/anti-carcinogenic benefits of anti-oxidants, such as vitamins C and E, melatonin, green tea, zinc, and selenium. There is, however, a limited amount of literature on the quantity of UV exposure in high-risk settings, such as extreme altitude and equatorial zones. Currently, there is no literature on UV exposure on Mount Everest. Additionally, the efficacy of antioxidants (topical or systemic) has not yet been established in this environment.

This will be an observational study where the principal investigator will collect accumulated ultraviolet exposure at different extreme altitudes during a 6 week period of a summit expedition on the north side of Mt. Everest. Included in the data collection will be patient demographics, time, altitude, temperature, use of anti-oxidants, sunscreen (weighed), and skin erythema (spectophotometer).

Recruitment information / eligibility
Status Completed
Enrollment 25
Est. completion date June 2007
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Participants part of the expedition who are willing to wear the monitor, and disclose information of diet/antioxidant supplements and topical sunblock.

Exclusion Criteria:

- Participants who are unwilling to carry the UV monitor or disclose their demographics

Study Design

Observational Model: Ecologic or Community, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Nepal Mount Everest, North side Kathmandu

Sponsors (2)
Lead Sponsor Collaborator
Sunnybrook Health Sciences Centre Ontario Centres of Excellence

Country where clinical trial is conducted

Nepal, 

References & Publications (9)

Bailey DM, Kleger GR, Holzgraefe M, Ballmer PE, Bärtsch P. Pathophysiological significance of peroxidative stress, neuronal damage, and membrane permeability in acute mountain sickness. J Appl Physiol (1985). 2004 Apr;96(4):1459-63. Epub 2003 Oct 31. — View Citation

Bartsch P, Bailey DM, Berger MM, Knauth M, Baumgartner RW. Acute mountain sickness: controversies and advances. High Alt Med Biol. 2004 Summer;5(2):110-24. Review. — View Citation

IARC monographs on the evaluation of carcinogenic risks to humans. Solar and ultraviolet radiation. IARC Monogr Eval Carcinog Risks Hum. 1992;55:1-316. Review. — View Citation

Moehrle M, Dennenmoser B, Garbe C. Continuous long-term monitoring of UV radiation in professional mountain guides reveals extremely high exposure. Int J Cancer. 2003 Mar 1;103(6):775-8. — View Citation

Moehrle M, Garbe C. Does mountaineering increase the incidence of cutaneous melanoma? A hypothesis based on cancer registry data. Dermatology. 1999;199(3):201-3. — View Citation

Moehrle M, Garbe C. Personal UV dosimetry by Bacillus subtilis spore films. Dermatology. 2000;200(1):1-5. — View Citation

Nishigori C. Cellular aspects of photocarcinogenesis. Photochem Photobiol Sci. 2006 Feb;5(2):208-14. Epub 2005 Dec 1. Review. — View Citation

Pinnell SR. Cutaneous photodamage, oxidative stress, and topical antioxidant protection. J Am Acad Dermatol. 2003 Jan;48(1):1-19; quiz 20-2. Review. — View Citation

Solorzano et al. Columbia: 40 Million People Exposed to Extreme Ultraviolet Radiation During the Whole Year. Radiation Protection Dosimetry 2000; 91(1-3): 325-328

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