Ignite Creation Date:
2025-12-24 @ 4:57 PM
Ignite Modification Date:
2026-01-23 @ 1:39 PM
Study NCT ID:
NCT02275650
Status:
COMPLETED
Last Update Posted:
2014-10-27
First Post:
2014-10-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of Narrowband Ultraviolet B Exposure in the Maintenance of Vitamin D Levels During Winter
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014808', 'term': 'Vitamin D Deficiency'}, {'id': 'D019294', 'term': 'Xanthomatosis, Cerebrotendinous'}], 'ancestors': [{'id': 'D001361', 'term': 'Avitaminosis'}, {'id': 'D003677', 'term': 'Deficiency Diseases'}, {'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D008052', 'term': 'Lipid Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D014973', 'term': 'Xanthomatosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-23', 'studyFirstSubmitDate': '2014-10-19', 'studyFirstSubmitQcDate': '2014-10-23', 'lastUpdatePostDateStruct': {'date': '2014-10-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '25(OH)D level', 'timeFrame': 'up to 30 weeks', 'description': 'Serum 25(OH)D levels were measured at the onset and at weeks 6, 14, 20, 26 and 30.'}], 'secondaryOutcomes': [{'measure': 'CYP27A1 and CYP27B1 enzyme expression levels', 'timeFrame': 'up to 14 weeks', 'description': 'CYP27A1 and CYP27B1 enzyme expression levels will be analysed from 6mm punch biopsies at the onset and at week 14.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['calcidiol', '25(oh)d', 'nbUVB', 'cyp27A1', 'cyp27B1', 'vitamin D'], 'conditions': ['Vitamin D Deficiency']}, 'descriptionModule': {'briefSummary': 'The investigators investigated the ability of narrowband ultraviolet B (nbUVB) treatment in the maintenance of vitamin D levels achieved during the summer in Finland. The investigators randomized 37 subjects into groups of 17 and 18 subjects. The other group received 2 standard erythema doses (SED) nbUVB exposure every other week until week 24, and serum 25(OH)D levels were measured at the onset and at weeks 6, 14, 20, 26 and 30. The control group was not illuminated and serum samples were analyzed correspondingly. Punch biopsies were taken at the onset and at week 14 for CYP27A1 and CYP27B1 enzyme expression level analyses.', 'detailedDescription': 'The investigators investigated the ability of narrowband ultraviolet B (nbUVB) treatment in the maintenance of vitamin D levels achieved during the summer in Finland. The investigators randomized 37 subjects into groups of 17 and 18 subjects. The other group received 2 standard erythema doses (SED) nbUVB exposure every other week until week 24, and serum 25(OH)D levels were measured at the onset and at weeks 6, 14, 20, 26 and 30. The control group was not illuminated and serum samples were analyzed correspondingly. 6mm punch biopsies were taken at the onset and at week 14 for CYP27A1 and CYP27B1 enzyme expression level analyses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* age over 18\n* Fitzpacker's skin type II-IV\n\nExclusion Criteria:\n\n* age under 18\n* diseases that inhibit vitamin D metabolism or absorption\n* Fitzpacker's skin type I\n* history of skin cancer\n* vitamin D substitution 1 month before baseline or during study\n* sun holidays 1 month before baseline or during study"}, 'identificationModule': {'nctId': 'NCT02275650', 'briefTitle': 'The Role of Narrowband Ultraviolet B Exposure in the Maintenance of Vitamin D Levels During Winter', 'organization': {'class': 'OTHER', 'fullName': 'Joint Authority for Päijät-Häme Social and Health Care'}, 'officialTitle': 'The Role of Narrowband Ultraviolet B Exposure in the Maintenance of Vitamin D Levels During Winter', 'orgStudyIdInfo': {'id': 'maintenance_uv'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'nbUVB', 'description': '2 SED dose of nbUVB will be given every other week for this intervention group.', 'interventionNames': ['Radiation: nbUVB']}, {'type': 'NO_INTERVENTION', 'label': 'control', 'description': 'No nbUVB illumination will be given for the control group.'}], 'interventions': [{'name': 'nbUVB', 'type': 'RADIATION', 'description': '2 SED nbUVB exposure will be given every other week', 'armGroupLabels': ['nbUVB']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15850', 'city': 'Lahdenkylä', 'state': 'Pirkanmaa', 'country': 'Finland', 'facility': 'Päijät-Häme Central Hospital', 'geoPoint': {'lat': 62.35686, 'lon': 23.77617}}, {'zip': '33521', 'city': 'Tampere', 'state': 'Pirkanmaa', 'country': 'Finland', 'facility': 'Tampere University Hospital', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}], 'overallOfficials': [{'name': 'Toni T Karppinen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Päijät Häme Central Hospital'}, {'name': 'Erna Snellman, professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Tampere University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Joint Authority for Päijät-Häme Social and Health Care', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tampere University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}