Environmental Influences on Vitamin D Status (Alaska/Hawaii)
| Tracking Information | |||||
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| First Received Date ICMJE | October 24, 2008 | ||||
| Last Updated Date | October 24, 2008 | ||||
| Start Date ICMJE | July 2008 | ||||
| Primary Completion Date | August 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
To measure the prevailing 25D and Vitamin D levels in communities at diverse latitudes [ Time Frame: crosssectional ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Environmental Influences on Vitamin D Status | ||||
| Official Title ICMJE | Environmental Influences on Vitamin D Status | ||||
| Brief Summary | Vitamin D deficiency is a common problem. The principal source of vitamin D for humans is solar exposure, with cutaneous synthesis of vitamin D by photoconversion of 7-dehydrocholesterol in the skin to pre-vitamin D3. Latitude, altitude, season, skin pigmentation, and age are recognized factors that influence how much vitamin D can be made by solar exposure. However, the relative influences of each are largely unknown and we cannot reliably answer the question of how much sun exposure an individual needs at various latitudes and at various seasons in order to ensure normal vitamin D status. |
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| Detailed Description | Purpose of the study: To determine the effect of environmental influences on Vitamin D status. Specific Aims
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Cross-Sectional |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Age of Subjects: The subjects will be between ages 18-60. The upper age is limited to age 60 as aging skin is less able to make vitamin D, therefore a separate study of elderly people would be more appropriate. Racial and Ethnic Origin: Both sites have a diverse ethnic and racial population and the subjects will be as representative of the population as possible. |
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| Condition ICMJE | Vitamin D Deficiency | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 50 | ||||
| Completion Date | August 2008 | ||||
| Primary Completion Date | August 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 60 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00780247 | ||||
| Other Study ID Numbers ICMJE | Creighton6, WIRB approval 20080712 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Laura Armas, M D, Creighton University | ||||
| Study Sponsor ICMJE | Creighton University | ||||
| Collaborators ICMJE | Procter and Gamble | ||||
| Investigators ICMJE |
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| Information Provided By | Creighton University | ||||
| Verification Date | October 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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