Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2026-02-25 @ 11:03 PM
Study NCT ID:
NCT01741233
Status:
COMPLETED
Last Update Posted:
2013-08-01
First Post:
2012-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Genetics Behind Vitamin D Status (VitDgen)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014808', 'term': 'Vitamin D Deficiency'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-31', 'studyFirstSubmitDate': '2012-11-30', 'studyFirstSubmitQcDate': '2012-11-30', 'lastUpdatePostDateStruct': {'date': '2013-08-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'serum 25-hydroxyvitamin D', 'timeFrame': '10 days', 'description': 'Measures the vitamin D status i serum at baseline and at the end of the project'}], 'secondaryOutcomes': [{'measure': 'Skintest', 'timeFrame': '10 days', 'description': 'Optimize scientific; measures pigmentation and redness of the skin. Are measured at baseline and at end of project'}]}, 'conditionsModule': {'keywords': ['SNPs', 'vitamin D', 'Vitamin D status', 'UVB irradiation', 'genetics'], 'conditions': ['Vitamin D Deficiency']}, 'referencesModule': {'references': [{'pmid': '25527766', 'type': 'DERIVED', 'citation': 'Nissen J, Vogel U, Ravn-Haren G, Andersen EW, Madsen KH, Nexo BA, Andersen R, Mejborn H, Bjerrum PJ, Rasmussen LB, Wulf HC. Common variants in CYP2R1 and GC genes are both determinants of serum 25-hydroxyvitamin D concentrations after UVB irradiation and after consumption of vitamin D(3)-fortified bread and milk during winter in Denmark. Am J Clin Nutr. 2015 Jan;101(1):218-27. doi: 10.3945/ajcn.114.092148. Epub 2014 Nov 5.'}]}, 'descriptionModule': {'briefSummary': 'The overall purpose of the study is to investigate whether there is a relationship between 26 different single nucleotide polymorphisms (SNPs) in the vitamin D pathway, ultraviolet B (UV-B) irradiation of the skin and vitamin D status.\n\nThe hypothesis is that vitamin D status are influated by different genetic genotypes in the vitamin D pathway.', 'detailedDescription': 'In this study approximately 80 participants (over 18 years) are included. All the participants has previously participated in the VitmaD intervention study (NCT01184716) .\n\nParticipants will in total receive 4 times UV-B irradiation (3 SED) with two day apart each time, to stimulate vitamin D production in the skin. The participants skintype will be measured. The study starts in January 2013 and runs to the end of Marts 2013. During this winter period, it is in Denmark not possible to produce vitamin D in the skin through sunlight exposure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Health participants over 18 years, that previously participated in VitmaD intervention study\n\nExclusion Criteria:\n\n* skindiseases\n* intake of medicin that causes photosensitive skin\n* pregnant or nursing\n* sun vacation 3 month before the intervention\n* intake of vitamin D supplement 3 month before the intervention'}, 'identificationModule': {'nctId': 'NCT01741233', 'acronym': 'VitDgen', 'briefTitle': 'The Genetics Behind Vitamin D Status (VitDgen)', 'organization': {'class': 'OTHER', 'fullName': 'Technical University of Denmark'}, 'officialTitle': 'The Genetics Behind Vitamin D Status (VitDgen)', 'orgStudyIdInfo': {'id': 'H-4-2012-071'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'UV-B irraditation', 'description': 'VitDgen', 'interventionNames': ['Genetic: VitDgen']}], 'interventions': [{'name': 'VitDgen', 'type': 'GENETIC', 'armGroupLabels': ['UV-B irraditation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2400', 'city': 'Bispebjerg', 'state': 'Copenhagen', 'country': 'Denmark', 'facility': 'Bispebjerg Hospital', 'geoPoint': {'lat': 55.71017, 'lon': 12.53147}}, {'zip': '2860', 'city': 'Mørkhøj', 'state': 'Søborg', 'country': 'Denmark', 'facility': 'DTU / National Food Institute', 'geoPoint': {'lat': 55.72592, 'lon': 12.47021}}], 'overallOfficials': [{'name': 'Lone Rasmussen, M.Sc., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'DTU, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technical University of Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bispebjerg Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.Sc., Ph.D.', 'investigatorFullName': 'Lone Banke Rasmussen', 'investigatorAffiliation': 'Technical University of Denmark'}}}}