Ignite Creation Date:
2025-12-24 @ 3:33 PM
Ignite Modification Date:
2026-02-25 @ 6:58 PM
Study NCT ID:
NCT02334592
Status:
COMPLETED
Last Update Posted:
2015-01-08
First Post:
2015-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vitamin D Production Levels Achieved by Sunbed Tanning
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 87}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-07', 'studyFirstSubmitDate': '2015-01-06', 'studyFirstSubmitQcDate': '2015-01-07', 'lastUpdatePostDateStruct': {'date': '2015-01-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-01-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To characterize serum 25(OH)D response to regular sunbed use, when performed according to the RED Act exposure time guidelines', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'To characterize serum 25(OH)D response with respect to sunbed lamp output (100W, 160W and High Pressure).', 'timeFrame': '12 weeks'}, {'measure': 'To characterize serum 25(OH)D level with respect to skin lightness.', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['the effect of tanning', 'vitamin D production'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '29484099', 'type': 'DERIVED', 'citation': 'Kimball SM, Lee J, Vieth R. Sunbeds with UVB radiation can produce physiological levels of serum 25-Hydroxyvitamin D in healthy volunteers. Dermatoendocrinol. 2017 Oct 17;9(1):e1375635. doi: 10.1080/19381980.2017.1375635. eCollection 2017.'}]}, 'descriptionModule': {'briefSummary': 'Health Canada\'s Radiation Emitting Devices (RED) Act provides exposure time guidelines for sunbed use. These guidelines are intended to protect sunbed users from overexposure to UV radiation. Overexposure is defined as "exposure that exceeds the amount needed for vitamin D production and could lead to skin or eye damage. Acute overexposure induces sunburn." However, the effect of the recommended time exposure schedule on serum 25(OH)D response has not been characterized. Further, it is unknown if the maximum time exposures are required to reach and/or maintain optimal 25(OH)D levels. The aim of the current study is to characterize serum 25(OH)D response to regular sunbed use following the time exposure schedule recommended by Health Canada.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years and older, male or female\n\nExclusion Criteria:\n\n* History of skin cancer, granulomatous disease, liver disease, or kidney disease\n* Photosensitive medications\n* Pregnancy\n* Vitamin D supplementation within last 60 days\n* Sunbed use within last 60 days\n* Planned travel to sunny destination during study period (January to April 2014)'}, 'identificationModule': {'nctId': 'NCT02334592', 'briefTitle': 'Vitamin D Production Levels Achieved by Sunbed Tanning', 'organization': {'class': 'OTHER', 'fullName': 'Vitamin D Society'}, 'officialTitle': "The Impact of Health Canada's Sunbed Exposure Time Guidelines on Serum 25(OH)D Concentrations", 'orgStudyIdInfo': {'id': 'VDS-1234'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low Pressure 100W sunbed', 'interventionNames': ['Radiation: Sunbed tanning']}, {'type': 'EXPERIMENTAL', 'label': 'Low Pressure 160W sunbed', 'interventionNames': ['Radiation: Sunbed tanning']}, {'type': 'EXPERIMENTAL', 'label': 'High Pressure sunbed', 'interventionNames': ['Radiation: Sunbed tanning']}, {'type': 'NO_INTERVENTION', 'label': 'Control group'}], 'interventions': [{'name': 'Sunbed tanning', 'type': 'RADIATION', 'description': "Invention groups undergo a 12-week tanning protocol that follows Health Canada's RED Act", 'armGroupLabels': ['High Pressure sunbed', 'Low Pressure 100W sunbed', 'Low Pressure 160W sunbed']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vitamin D Society', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}