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| Tracking Information | |||||||||
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| First Received Date ICMJE | May 22, 2008 | ||||||||
| Last Updated Date | May 27, 2008 | ||||||||
| Start Date ICMJE | April 2007 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE | |||||||||
| Original Primary Outcome Measures ICMJE | |||||||||
| Change History | Complete list of historical versions of study NCT00685438 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Ultraviolet Exposure, Antioxidant Use and Skin Erythema at Extreme High Altitude | ||||||||
| Official Title ICMJE | Observational Study of Skin Erythema by Spectrophotometer, and UV Exposure With Viospore Ultraviolet Monitors at Extreme Altitude (Mt. Everest, North Side) | ||||||||
| 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:
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| 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). |
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| Study Phase | |||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Ecologic or Community, Prospective | ||||||||
| Condition ICMJE |
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| Intervention ICMJE | |||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 25 | ||||||||
| Completion Date | June 2007 | ||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | |||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Nepal | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00685438 | ||||||||
| Responsible Party | Ivy Cheng, Sunnybrook Health Sciences Center | ||||||||
| Study ID Numbers ICMJE | 005-2007 | ||||||||
| Study Sponsor ICMJE | Sunnybrook Health Sciences Centre | ||||||||
| Collaborators ICMJE | Ontario Centres of Excellence | ||||||||
| Investigators ICMJE |
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| Information Provided By | Sunnybrook Health Sciences Centre | ||||||||
| Verification Date | May 2008 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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