AltitudeNCT00685438
Ultraviolet Exposure, Antioxidant Use and Skin Erythema at Extreme High Altitude
An observational study of Altitude and Ultraviolet Rays, run by Sunnybrook Health Sciences Centre at 1 site in Nepal.
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). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Altitude, Ultraviolet Rays, Antioxidants
- How many people
- 25 participants
- Where
- 1 siteNepal
- Study dates
- Apr 2007to Jun 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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)
Who may be able to join
- Participants part of the expedition who are willing to wear the monitor, and disclose information of diet/antioxidant supplements and topical sunblock.
Who cannot join
- Participants who are unwilling to carry the UV monitor or disclose their demographics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Study of Skin Erythema by Spectrophotometer, and UV Exposure With Viospore Ultraviolet Monitors at Extreme Altitude (Mt. Everest, North Side)
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:
- 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.
- The skin is an accurate reflection of UV and oxidative stress exposure
- The efficacy of oxidatives stress is reflective of the ethnicity of the individual.
Read the detailed 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).
- Conditions
- Altitude, Ultraviolet Rays, Antioxidants, Oxidative Stress, Erythema
- Keywords
- Environmental Medicine, Altitude, Ultraviolet Rays, Antioxidants, Oxidative Stress, Erythema
- Medical subject headings
- Erythema
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2008 (estimated)
- Study startApr 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for AltitudeStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Centres of Excellence
- Investigators
- Ivy S Cheng, MD, Principal investigator, Sunnybrook Hospital Emergency DepartmentLothar D Lilge, PhD, Principal investigator, Ontario Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00685438
- Sponsor's protocol ID
- 005-2007
- Status last verified
- May 2008
- First submitted
- 22 May 2008
- Last updated
- 28 May 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Solar and ultraviolet radiation. IARC Monogr Eval Carcinog Risks Hum. 1992;55:1-316. No abstract available.
PubMed 1345607Nishigori C. Cellular aspects of photocarcinogenesis. Photochem Photobiol Sci. 2006 Feb;5(2):208-14. doi: 10.1039/b507471a. Epub 2005 Dec 1.
PubMed 16465307Pinnell 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.
PubMed 12522365Moehrle 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.
PubMed 12516097Solorzano et al. Columbia: 40 Million People Exposed to Extreme Ultraviolet Radiation During the Whole Year. Radiation Protection Dosimetry 2000; 91(1-3): 325-328
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.
PubMed 10592397Bartsch 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.
PubMed 15265333Bailey 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.
PubMed 14594861Moehrle M, Garbe C. Personal UV dosimetry by Bacillus subtilis spore films. Dermatology. 2000;200(1):1-5. doi: 10.1159/000018306.
PubMed 10681605Cheng 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.
PubMed 24075057
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Skin Erythema by Spectrophotometer, and UV Exposure With Viospore Ultraviolet Monitors at Extreme Altitude (Mt. Everest, North Side)
- ClinicalTrials.gov ID
- NCT00685438
- Acronym / sponsor ID
- 005-2007
- Conditions
- Altitude, Ultraviolet Rays, Antioxidants, Oxidative Stress, Erythema
- Keywords
- Environmental Medicine, Altitude, Ultraviolet Rays, Antioxidants, Oxidative Stress, Erythema
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- Ontario Centres of Excellence
- Study start
- Apr 2007
- Study completion
- Jun 2007 (actual)
- First posted
- 28 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- The skin is an accurate reflection of UV and oxidative stress exposure
- The efficacy of oxidatives stress is reflective of the ethnicity of the individual.
Detailed 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).
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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)
Key inclusion criteria (1 listed)
- Participants part of the expedition who are willing to wear the monitor, and disclose information of diet/antioxidant supplements and topical sunblock.
Key exclusion criteria (1 listed)
- Participants who are unwilling to carry the UV monitor or disclose their demographics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2008.
- Background: PubMed 1345607Solar and ultraviolet radiation. IARC Monogr Eval Carcinog Risks Hum. 1992;55:1-316. No abstract available.
- Background: PubMed 16465307Nishigori C. Cellular aspects of photocarcinogenesis. Photochem Photobiol Sci. 2006 Feb;5(2):208-14. doi: 10.1039/b507471a. Epub 2005 Dec 1.
- Background: PubMed 12522365Pinnell 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.
- Background: PubMed 12516097Moehrle 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.
- BackgroundSolorzano 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: PubMed 10592397Moehrle 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.
- Background: PubMed 15265333Bartsch 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.
- Background: PubMed 14594861Bailey 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.
- Background: PubMed 10681605Moehrle M, Garbe C. Personal UV dosimetry by Bacillus subtilis spore films. Dermatology. 2000;200(1):1-5. doi: 10.1159/000018306.
- Derived from this study: PubMed 24075057Cheng 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.
- Ultraviolet monitors being usedLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ivy S Cheng, MD principal investigator
Sunnybrook Hospital Emergency Department
Lothar D Lilge, PhD principal investigator
Ontario Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Altitude and Ultraviolet Rays, run by Sunnybrook Health Sciences Centre at 1 site in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00685438, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2008.