NCT00685438

Brief 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. 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. 2.The skin is an accurate reflection of UV and oxidative stress exposure
  3. 3.The efficacy of oxidatives stress is reflective of the ethnicity of the individual.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2007

Shorter than P25 for all trials

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

April 1, 2007

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 28, 2008

Completed
Last Updated

May 28, 2008

Status Verified

May 1, 2008

First QC Date

May 22, 2008

Last Update Submit

May 27, 2008

Conditions

AltitudeUltraviolet RaysAntioxidantsOxidative StressErythema

Keywords

Environmental MedicineAltitudeUltraviolet RaysAntioxidantsOxidative StressErythema

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

9 Mountaineers with intention to summit Everest (1 American, 1 British, 1 German, 5 Australians, 1 Asian-Australian) 4 Trekkers with intention to go to 7000m (2 Americans, 1 Asian, 1 British) 12 climbing sherpas (11 Nepali and 1 Tibetan)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Everest, North side

Kathmandu, Nepal

Location

Related Publications (10)

  • Solar and ultraviolet radiation. IARC Monogr Eval Carcinog Risks Hum. 1992;55:1-316. No abstract available.

    PMID: 1345607BACKGROUND

  • Nishigori C. Cellular aspects of photocarcinogenesis. Photochem Photobiol Sci. 2006 Feb;5(2):208-14. doi: 10.1039/b507471a. Epub 2005 Dec 1.

    PMID: 16465307BACKGROUND

  • Pinnell SR. Cutaneous photodamage, oxidative stress, and topical antioxidant protection. J Am Acad Dermatol. 2003 Jan;48(1):1-19; quiz 20-2. doi: 10.1067/mjd.2003.16.

    PMID: 12522365BACKGROUND

  • 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. doi: 10.1002/ijc.10884.

    PMID: 12516097BACKGROUND

  • 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

    BACKGROUND

  • 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. doi: 10.1159/000018274.

    PMID: 10592397BACKGROUND

  • 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. doi: 10.1089/1527029041352108.

    PMID: 15265333BACKGROUND

  • Bailey DM, Kleger GR, Holzgraefe M, Ballmer PE, Bartsch 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. doi: 10.1152/japplphysiol.00704.2003. Epub 2003 Oct 31.

    PMID: 14594861BACKGROUND

  • Moehrle M, Garbe C. Personal UV dosimetry by Bacillus subtilis spore films. Dermatology. 2000;200(1):1-5. doi: 10.1159/000018306.

    PMID: 10681605BACKGROUND

  • Cheng I, Kiss A, Lilge L. An observational study of personal ultraviolet dosimetry and acute diffuse reflectance skin changes at extreme altitude. Wilderness Environ Med. 2013 Dec;24(4):390-6. doi: 10.1016/j.wem.2013.05.007. Epub 2013 Sep 25.

    PMID: 24075057DERIVED

Related Links

MeSH Terms

Conditions

Erythema

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue DiseasesSkin ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ivy S Cheng, MD

    Sunnybrook Hospital Emergency Department

    PRINCIPAL INVESTIGATOR

  • Lothar D Lilge, PhD

    Ontario Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 22, 2008

First Posted

May 28, 2008

Study Start

April 1, 2007

Study Completion

June 1, 2007

Last Updated

May 28, 2008

Record last verified: 2008-05

Locations

NE(1)