{ "FullStudy":{ "Rank":218115, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01512537", "OrgStudyIdInfo":{ "OrgStudyId":"2009/687" }, "Organization":{ "OrgFullName":"Lund University", "OrgClass":"OTHER" }, "BriefTitle":"Alternative Treatments of Vitamin D Deficiency", "OfficialTitle":"Comparison of UVB and Vitamin D Supplementation in Treatment of Vitamin D Deficiency" }, "StatusModule":{ "StatusVerifiedDate":"January 2012", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"February 2010" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"April 2011", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"November 2011", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"December 22, 2011", "StudyFirstSubmitQCDate":"January 15, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 19, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"January 15, 2012", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"January 19, 2012", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Principal Investigator", "ResponsiblePartyInvestigatorFullName":"Morten Bogh", "ResponsiblePartyInvestigatorTitle":"Principal Investigator", "ResponsiblePartyInvestigatorAffiliation":"Lund University" }, "LeadSponsor":{ "LeadSponsorName":"Lund University", "LeadSponsorClass":"OTHER" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"The purpose of the study is to compare the efficiency of UVB and vitamin D supplementation in treatment of vitamin D deficiency.", "DetailedDescription":"Patients with vitamin D deficiency were recruited and randomized into two groups, one exposed to UVB and the other receiving oral treatment with vitamin D supplementation." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Vitamin D Deficiency" ] }, "KeywordList":{ "Keyword":[ "Vitamin D", "UVB", "Vitamin D supplementation" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Not Applicable" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Basic Science", "DesignMaskingInfo":{ "DesignMasking":"Double", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Investigator" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"32", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"UVB", "ArmGroupType":"Active Comparator", "ArmGroupDescription":"UVB exposed group", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Radiation: Narrowband UVB" ] } },{ "ArmGroupLabel":"Oral vitamin D tablet", "ArmGroupType":"Active Comparator", "ArmGroupDescription":"Vitamin D supplementation", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Dietary Supplement: Vitamin D and calcium" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Radiation", "InterventionName":"Narrowband UVB", "InterventionDescription":"UVB 3 times a week", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "UVB" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "NB-UVB" ] } },{ "InterventionType":"Dietary Supplement", "InterventionName":"Vitamin D and calcium", "InterventionDescription":"1 daily tablet of 1600 IU vitamin D3 and 1000 mg calcium", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Oral vitamin D tablet" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Vitamin D supplementation" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Vitamin D (nmol/l).", "PrimaryOutcomeDescription":"Vitamin D was measured in a bloodsample to determine baseline status.", "PrimaryOutcomeTimeFrame":"Week 0" },{ "PrimaryOutcomeMeasure":"Vitamin D (nmol/l)", "PrimaryOutcomeDescription":"Vitamin D was measured in a bloodsample to follow the change from baseline in vitamin D level at week 3.", "PrimaryOutcomeTimeFrame":"Week 3" },{ "PrimaryOutcomeMeasure":"Vitamin D", "PrimaryOutcomeDescription":"Vitamin D was measured in a bloodsample to follow the change from baseline in vitamin D level at week 6.", "PrimaryOutcomeTimeFrame":"Week 6" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Parathyroid hormone (pmol/l).", "SecondaryOutcomeDescription":"To investigate whether parathyrodiea hormone changes during the study.", "SecondaryOutcomeTimeFrame":"Week 0, 3 and 6." },{ "SecondaryOutcomeMeasure":"Albumin (g/l).", "SecondaryOutcomeDescription":"To investigate whether albumin changes during the study.", "SecondaryOutcomeTimeFrame":"Week 0, 3 and 6." },{ "SecondaryOutcomeMeasure":"Calcium (mmol/l)", "SecondaryOutcomeDescription":"To investigate whether calcium changes during the study.", "SecondaryOutcomeTimeFrame":"Week 0, 3 and 6." },{ "SecondaryOutcomeMeasure":"Hemoglobin A 1c (percentage HbA1c of total hemoglobin).", "SecondaryOutcomeDescription":"To investigate whether HbA1c changes during the study.", "SecondaryOutcomeTimeFrame":"Week 0, 3 and 6." } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nVitamin D deficiency (< 25 nmol/l)\nAge 15 or above\n\nExclusion Criteria:\n\nTravel south of 45 degrees latitude during the trial.\nOngoing treatment with vitamin D supplementation.\nIntake of light sensitive medicine, such as tetracyclins.\nSkin light eruptions", "HealthyVolunteers":"Accepts Healthy Volunteers", "Gender":"All", "MinimumAge":"15 Years", "MaximumAge":"70 Years", "StdAgeList":{ "StdAge":[ "Child", "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Åke Svensson, Assoc. Prof., MD, PhD", "OverallOfficialAffiliation":"Department of Dermatology, Lund University, Malmoe", "OverallOfficialRole":"Study Chair" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Department of Dermatology, Lund University Malmoe", "LocationCity":"Malmoe", "LocationZip":"205 02", "LocationCountry":"Sweden" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000014807", "InterventionMeshTerm":"Vitamin D" },{ "InterventionMeshId":"D000004872", "InterventionMeshTerm":"Ergocalciferols" },{ "InterventionMeshId":"D000014815", "InterventionMeshTerm":"Vitamins" },{ "InterventionMeshId":"D000002118", "InterventionMeshTerm":"Calcium" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000018977", "InterventionAncestorTerm":"Micronutrients" },{ "InterventionAncestorId":"D000078622", "InterventionAncestorTerm":"Nutrients" },{ "InterventionAncestorId":"D000006133", "InterventionAncestorTerm":"Growth Substances" },{ "InterventionAncestorId":"D000045505", "InterventionAncestorTerm":"Physiological Effects of Drugs" },{ "InterventionAncestorId":"D000077264", "InterventionAncestorTerm":"Calcium-Regulating Hormones and Agents" },{ "InterventionAncestorId":"D000050071", "InterventionAncestorTerm":"Bone Density Conservation Agents" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M16133", "InterventionBrowseLeafName":"Vitamin D", "InterventionBrowseLeafAsFound":"Vitamin D", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M16141", "InterventionBrowseLeafName":"Vitamins", "InterventionBrowseLeafAsFound":"Vitamin", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M3963", "InterventionBrowseLeafName":"Calcium", "InterventionBrowseLeafAsFound":"Calcium", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M3980", "InterventionBrowseLeafName":"Calcium, Dietary", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M6609", "InterventionBrowseLeafName":"Ergocalciferols", "InterventionBrowseLeafAsFound":"Vitamin D", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M15468", "InterventionBrowseLeafName":"Trace Elements", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M19593", "InterventionBrowseLeafName":"Micronutrients", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M1986", "InterventionBrowseLeafName":"Nutrients", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M8372", "InterventionBrowseLeafName":"Hormones", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"T440", "InterventionBrowseLeafName":"Calciferol", "InterventionBrowseLeafAsFound":"Vitamin D", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"T445", "InterventionBrowseLeafName":"Ergocalciferol", "InterventionBrowseLeafAsFound":"Vitamin D", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"T478", "InterventionBrowseLeafName":"Vitamin D2", "InterventionBrowseLeafAsFound":"Vitamin D", "InterventionBrowseLeafRelevance":"high" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"BDCA", "InterventionBrowseBranchName":"Bone Density Conservation Agents" },{ "InterventionBrowseBranchAbbrev":"Micro", "InterventionBrowseBranchName":"Micronutrients" },{ "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" },{ "InterventionBrowseBranchAbbrev":"Vi", "InterventionBrowseBranchName":"Vitamins" } ] } }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000014808", "ConditionMeshTerm":"Vitamin D Deficiency" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000001361", "ConditionAncestorTerm":"Avitaminosis" },{ "ConditionAncestorId":"D000003677", "ConditionAncestorTerm":"Deficiency Diseases" },{ "ConditionAncestorId":"D000044342", "ConditionAncestorTerm":"Malnutrition" },{ "ConditionAncestorId":"D000009748", "ConditionAncestorTerm":"Nutrition Disorders" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M16134", "ConditionBrowseLeafName":"Vitamin D Deficiency", "ConditionBrowseLeafAsFound":"Vitamin D Deficiency", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M3241", "ConditionBrowseLeafName":"Avitaminosis", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M5462", "ConditionBrowseLeafName":"Deficiency Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M23893", "ConditionBrowseLeafName":"Malnutrition", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M11267", "ConditionBrowseLeafName":"Nutrition Disorders", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC18", "ConditionBrowseBranchName":"Nutritional and Metabolic Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" } ] } } } } } }