Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2025-12-31 @ 1:55 AM
Study NCT ID:
NCT00516867
Status:
COMPLETED
Last Update Posted:
2007-08-16
First Post:
2007-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Does Sunbed Radiation With Mainly UVA Provoke Cutaneous Vitamin D Synthesis in Humans?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014466', 'term': 'Ultraviolet Rays'}], 'ancestors': [{'id': 'D008027', 'term': 'Light'}, {'id': 'D060733', 'term': 'Electromagnetic Radiation'}, {'id': 'D055590', 'term': 'Electromagnetic Phenomena'}, {'id': 'D060328', 'term': 'Magnetic Phenomena'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D055620', 'term': 'Optical Phenomena'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D011839', 'term': 'Radiation, Ionizing'}, {'id': 'D011840', 'term': 'Radiation, Nonionizing'}, {'id': 'D013472', 'term': 'Sunlight'}, {'id': 'D014887', 'term': 'Weather'}, {'id': 'D001272', 'term': 'Atmosphere'}, {'id': 'D004777', 'term': 'Environment'}, {'id': 'D055669', 'term': 'Ecological and Environmental Phenomena'}, {'id': 'D001686', 'term': 'Biological Phenomena'}, {'id': 'D008685', 'term': 'Meteorological Concepts'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-08', 'completionDateStruct': {'date': '2006-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-08-15', 'studyFirstSubmitDate': '2007-08-14', 'studyFirstSubmitQcDate': '2007-08-15', 'lastUpdatePostDateStruct': {'date': '2007-08-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-08-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum concentration of 25(OH)D', 'timeFrame': '18 Days'}], 'secondaryOutcomes': [{'measure': 'Serum concentration of PTH', 'timeFrame': '18 Days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'We would investigate in a controlled, randomized open study in the winter season: 1) If serum levels of vitamin D (25(OH)D) increase in subjects treated with sunbed with sunlamps emitting mainly UVA and only 0·5% or 1·4% UVB compared to non-sunbed treated controls 2) If yes, are the 25(OH)D serum levels then dependent on the UVB dose?'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy\n* Females\n* Above 50 years\n* Younger with serum concentration of 25(OH)D below 50nmol/l\n\nExclusion Criteria:\n\n* No sunbed use last ½ year\n* No sun holiday last ½ year\n* No intake of vitamin D above 10 microgram/day'}, 'identificationModule': {'nctId': 'NCT00516867', 'briefTitle': 'Does Sunbed Radiation With Mainly UVA Provoke Cutaneous Vitamin D Synthesis in Humans?', 'organization': {'class': 'OTHER', 'fullName': 'Bispebjerg Hospital'}, 'officialTitle': 'Sunbed Radiation Provoke Cutaneous Vitamin D Synthesis in Humans, a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'KF 01 290815'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'UVB 0.5%', 'interventionNames': ['Radiation: UV radiation']}, {'type': 'NO_INTERVENTION', 'label': 'Controls'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'UVB 1.4%', 'interventionNames': ['Radiation: UV radiation']}], 'interventions': [{'name': 'UV radiation', 'type': 'RADIATION', 'description': 'UV radiation with 99.5% UVA and 0.5%UVB', 'armGroupLabels': ['UVB 0.5%']}, {'name': 'UV radiation', 'type': 'RADIATION', 'description': 'UVB 1.4 % and UVA 98.6', 'armGroupLabels': ['UVB 1.4%']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DK-2000 NV', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Bispebjerg Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Hans C Wulf, MD, DSc', 'role': 'STUDY_CHAIR', 'affiliation': 'Bispebjerg Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bispebjerg Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hvidovre University Hospital', 'class': 'OTHER'}]}}}