Production of Vitamin D Metabolites by UV-radiation From Solar Bed
| Tracking Information | |||||||||||||||||
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| First Received Date ICMJE | December 15, 2010 | ||||||||||||||||
| Last Updated Date | March 15, 2012 | ||||||||||||||||
| Start Date ICMJE | April 2010 | ||||||||||||||||
| Primary Completion Date | February 2011 (final data collection date for primary outcome measure) | ||||||||||||||||
| Current Primary Outcome Measures ICMJE |
Vitamin D 25-OHD [ Time Frame: 8 days ] [ Designated as safety issue: No ] | ||||||||||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||
| Change History | Complete list of historical versions of study NCT01261039 on ClinicalTrials.gov Archive Site | ||||||||||||||||
| Current Secondary Outcome Measures ICMJE |
Changes in other calcium metabolic factors [ Time Frame: 8 days ] [ Designated as safety issue: No ] Vitamin D3, Mg++, PTH, PO4--, Ca++ |
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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 | Production of Vitamin D Metabolites by UV-radiation From Solar Bed | ||||||||||||||||
| Official Title ICMJE | Production of Vitamin D Metabolites by UV-radiation From Solar Bed | ||||||||||||||||
| Brief Summary | Background: Some patients do not readily absorb vitamin D from intestine. These patients may be helped by ultraviolet rays, which can come from sunlight or solar beds. When the skin is exposed to ultraviolet B rays (UVB) vitamin D is produced. This usually happens when the skin is exposed to sunlight. Vitamin D can also be ingested trough some foods, mainly fatty fish or supplements. Vitamin D is important for bone, and long-term vitamin D deficiency can lead to osteoporosis. Vitamin D may also be important for the immune system—including autoimmune diseases—and the cardiovascular system. Purpose: The main purpose of the study is to learn more about the production of vitamin D3 in the skin, by ultraviolet radiation. Study Course: Day 0: Randomization. Subjects are randomized to two groups. Subjects in both groups will be exposed to light in a solar bed for approximately 10 minutes on the first day, but only one of the solar beds wields ultraviolet rays. The other has a filter, which filters out the ultraviolet rays. Blood samples are drawn on the first day at following times: Before solar bed, after at 15 minutes, 1, 2, 4 and 6 hours. Day 1,2,3 and 7 after solar bed exposure: Blood samples are drawn and adverse events are registered. |
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| Detailed Description | Not Provided | ||||||||||||||||
| Study Type ICMJE | Interventional | ||||||||||||||||
| Study Phase | Not Provided | ||||||||||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Basic Science |
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| Condition ICMJE | Production of Vitamin D in Skin When Exposed to UV-B by Solar Bed. | ||||||||||||||||
| Intervention ICMJE | Radiation: UV radiation
Subjects in both groups will be exposed to light in a solar bed for approximately 10 minutes (depending on Fitzpatrick skin type test) on the first day, but only one of the solar beds wields ultraviolet rays. The other has a filter, which filters out the ultraviolet rays. |
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| Study Arm (s) |
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| Publications * | Langdahl JH, Schierbeck LL, Bang UC, Jensen JE. Changes in serum 25-hydroxyvitamin D and cholecalciferol after one whole-body exposure in a commercial tanning bed: a randomized study. Endocrine. 2012 Oct;42(2):430-5. Epub 2012 Mar 6. | ||||||||||||||||
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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 | 20 | ||||||||||||||||
| Completion Date | February 2011 | ||||||||||||||||
| Primary Completion Date | February 2011 (final data collection date for primary outcome measure) | ||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Healthy adults Exclusion Criteria: Abnormal ALT or Creatinine Pregnancy |
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| Gender | Both | ||||||||||||||||
| Ages | 18 Years and older | ||||||||||||||||
| Accepts Healthy Volunteers | Yes | ||||||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||
| Location Countries ICMJE | Denmark | ||||||||||||||||
| Administrative Information | |||||||||||||||||
| NCT Number ICMJE | NCT01261039 | ||||||||||||||||
| Other Study ID Numbers ICMJE | h-3-2009-145 | ||||||||||||||||
| Has Data Monitoring Committee | No | ||||||||||||||||
| Responsible Party | Louise Lind Schierbeck, Hvidovre University Hospital | ||||||||||||||||
| Study Sponsor ICMJE | Hvidovre University Hospital | ||||||||||||||||
| Collaborators ICMJE | Not Provided | ||||||||||||||||
| Investigators ICMJE |
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| Information Provided By | Hvidovre University Hospital | ||||||||||||||||
| Verification Date | March 2012 | ||||||||||||||||
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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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