{ "FullStudy":{ "Rank":217625, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01518959", "OrgStudyIdInfo":{ "OrgStudyId":"D-HEM" }, "Organization":{ "OrgFullName":"Semmelweis University", "OrgClass":"OTHER" }, "BriefTitle":"The Effect of 25-OH-Vitamin-D3 Substitution in Patients With Malignant and Immune-hematologic Diseases", "OfficialTitle":"Phase III, Controlled, Double-blind, Randomized Study of 25-OH-Vitamin-D3 Substitution in Patients With Malignant and Immune-hematologic Diseases", "Acronym":"D-HEM" }, "StatusModule":{ "StatusVerifiedDate":"November 2014", "OverallStatus":"Unknown status", "LastKnownStatus":"Recruiting", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"January 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"January 2017", "PrimaryCompletionDateType":"Anticipated" }, "StudyFirstSubmitDate":"January 6, 2012", "StudyFirstSubmitQCDate":"January 25, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 26, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"November 18, 2014", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"November 20, 2014", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Principal Investigator", "ResponsiblePartyInvestigatorFullName":"Istvan Takacs", "ResponsiblePartyInvestigatorTitle":"Clinical Professor", "ResponsiblePartyInvestigatorAffiliation":"Semmelweis University" }, "LeadSponsor":{ "LeadSponsorName":"Semmelweis University", "LeadSponsorClass":"OTHER" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"Recent data have shown that the inadequate vitamin D status plays a role in the manifestation of the haematologic tumors and serum vitamin D level has a prognostic role also as it determines the tumor mortality. But data have not proved a causal relationship between the inadequate vitamin D status and the unfavourable outcomes so far. It is also still unknown, whether the normalization of vitamin D status in patient with vitamin D inadequacy is able to improve the prognosis and survival.\n\nIn this study the investigators examine the role of the adequate vitamin D substitution in the improvement of the outcomes of haematologic disorders." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Chronic Lymphoid Leukemia" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 3" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"Quadruple", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Care Provider", "Investigator", "Outcomes Assessor" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"50", "EnrollmentType":"Anticipated" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Placebo", "ArmGroupType":"Placebo Comparator", "ArmGroupDescription":"no treatment", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: oleum neutralicum" ] } },{ "ArmGroupLabel":"Cholecalcipherol", "ArmGroupType":"Active Comparator", "ArmGroupDescription":"Treatment with 180 000 IU cholecalcipherol monthly", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Cholecalciferol" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"Cholecalciferol", "InterventionDescription":"180.000 IU monthly", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Cholecalcipherol" ] } },{ "InterventionType":"Drug", "InterventionName":"oleum neutralicum", "InterventionDescription":"Placebo comparator, 9 ml monthly", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Placebo" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Overall survival", "PrimaryOutcomeTimeFrame":"up to 5 years" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Time to treatment needed", "SecondaryOutcomeTimeFrame":"up to 5 years" },{ "SecondaryOutcomeMeasure":"Blood lymphocyte count", "SecondaryOutcomeTimeFrame":"monthly, up to 5 years" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nat least 18 years old male or female\nchronic lymphoid leukaemia, any Rai stage\n25-OH-Vitamin-D3 level between 10 and 30 ng/mL\n\nExclusion Criteria:\n\nserum calcium > 2,60 mmol/l\n24 hour calcium urine excretion > 0,1 mmol/kg/day\nserum phosphate > 1,45 mmol/l\neGFR < 30 ml/min/1,73m2\nnephrolithiasis\nreceiving parenteral vitamin-D3 in past 6 months\nactivated vitamin-D3 treatment", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "CentralContactList":{ "CentralContact":[ { "CentralContactName":"Istvan Takacs, M.D., Ph.D.", "CentralContactRole":"Contact", "CentralContactPhone":"+36-1-210-0278", "CentralContactPhoneExt":"51500", "CentralContactEMail":"takist@bel1.sote.hu" } ] }, "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Istvan Takacs, MD, PhD", "OverallOfficialAffiliation":"Semmelweis University", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Semmelweis University - 1st Departement of Internal Medicine", "LocationStatus":"Recruiting", "LocationCity":"Budapest", "LocationZip":"1083", "LocationCountry":"Hungary", "LocationContactList":{ "LocationContact":[ { "LocationContactName":"Istvan Takacs, MD, PhD", "LocationContactRole":"Contact", "LocationContactPhone":"+36-1-210-0278", "LocationContactPhoneExt":"51500", "LocationContactEMail":"takist@bel1.sote.hu" },{ "LocationContactName":"Istvan Takacs, MD, PhD", "LocationContactRole":"Principal Investigator" } ] } } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000002762", "InterventionMeshTerm":"Cholecalciferol" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000077264", "InterventionAncestorTerm":"Calcium-Regulating Hormones and Agents" },{ "InterventionAncestorId":"D000045505", "InterventionAncestorTerm":"Physiological Effects of Drugs" },{ "InterventionAncestorId":"D000014815", "InterventionAncestorTerm":"Vitamins" },{ "InterventionAncestorId":"D000018977", "InterventionAncestorTerm":"Micronutrients" },{ "InterventionAncestorId":"D000078622", "InterventionAncestorTerm":"Nutrients" },{ "InterventionAncestorId":"D000006133", "InterventionAncestorTerm":"Growth Substances" },{ "InterventionAncestorId":"D000050071", "InterventionAncestorTerm":"Bone Density Conservation Agents" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M4586", "InterventionBrowseLeafName":"Cholecalciferol", "InterventionBrowseLeafAsFound":"Cholecalciferol", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M3963", "InterventionBrowseLeafName":"Calcium", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M3980", "InterventionBrowseLeafName":"Calcium, Dietary", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M8372", "InterventionBrowseLeafName":"Hormones", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M16141", "InterventionBrowseLeafName":"Vitamins", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M15468", "InterventionBrowseLeafName":"Trace Elements", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M19593", "InterventionBrowseLeafName":"Micronutrients", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M1986", "InterventionBrowseLeafName":"Nutrients", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"T440", "InterventionBrowseLeafName":"Calciferol", "InterventionBrowseLeafAsFound":"Cholecalciferol", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"T442", "InterventionBrowseLeafName":"Cholecalciferol", "InterventionBrowseLeafAsFound":"Cholecalciferol", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"T479", "InterventionBrowseLeafName":"Vitamin D3", "InterventionBrowseLeafAsFound":"Cholecalciferol", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"T242", "InterventionBrowseLeafName":"Olive", "InterventionBrowseLeafRelevance":"low" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"BDCA", "InterventionBrowseBranchName":"Bone Density Conservation Agents" },{ "InterventionBrowseBranchAbbrev":"Micro", "InterventionBrowseBranchName":"Micronutrients" },{ "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" },{ "InterventionBrowseBranchAbbrev":"Vi", "InterventionBrowseBranchName":"Vitamins" },{ "InterventionBrowseBranchAbbrev":"HB", "InterventionBrowseBranchName":"Herbal and Botanical" } ] } }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000007945", "ConditionMeshTerm":"Leukemia, Lymphoid" },{ "ConditionMeshId":"D000015451", "ConditionMeshTerm":"Leukemia, Lymphocytic, Chronic, B-Cell" },{ "ConditionMeshId":"D000006402", "ConditionMeshTerm":"Hematologic Diseases" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000007938", "ConditionAncestorTerm":"Leukemia" },{ "ConditionAncestorId":"D000009370", "ConditionAncestorTerm":"Neoplasms by Histologic Type" },{ "ConditionAncestorId":"D000009369", "ConditionAncestorTerm":"Neoplasms" },{ "ConditionAncestorId":"D000008232", "ConditionAncestorTerm":"Lymphoproliferative Disorders" },{ "ConditionAncestorId":"D000008206", "ConditionAncestorTerm":"Lymphatic Diseases" },{ "ConditionAncestorId":"D000007160", "ConditionAncestorTerm":"Immunoproliferative Disorders" },{ "ConditionAncestorId":"D000007154", "ConditionAncestorTerm":"Immune System Diseases" },{ "ConditionAncestorId":"D000015448", "ConditionAncestorTerm":"Leukemia, B-Cell" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M16699", "ConditionBrowseLeafName":"Leukemia, Lymphocytic, Chronic, B-Cell", "ConditionBrowseLeafAsFound":"Chronic Lymphoid Leukemia", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M8073", "ConditionBrowseLeafName":"Hematologic Diseases", "ConditionBrowseLeafAsFound":"Hematologic Diseases", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M9528", "ConditionBrowseLeafName":"Leukemia", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M9534", "ConditionBrowseLeafName":"Leukemia, Lymphoid", "ConditionBrowseLeafAsFound":"Lymphoid Leukemia", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M10898", "ConditionBrowseLeafName":"Neoplasms by Histologic Type", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M9808", "ConditionBrowseLeafName":"Lymphoproliferative Disorders", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M9786", "ConditionBrowseLeafName":"Lymphatic Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M8789", "ConditionBrowseLeafName":"Immunoproliferative Disorders", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M8783", "ConditionBrowseLeafName":"Immune System Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M16698", "ConditionBrowseLeafName":"Leukemia, B-Cell", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"T1315", "ConditionBrowseLeafName":"Chronic Lymphocytic Leukemia", "ConditionBrowseLeafAsFound":"Chronic Lymphoid Leukemia", "ConditionBrowseLeafRelevance":"high" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC04", "ConditionBrowseBranchName":"Cancers and Other Neoplasms" },{ "ConditionBrowseBranchAbbrev":"BC15", "ConditionBrowseBranchName":"Blood and Lymph Conditions" },{ "ConditionBrowseBranchAbbrev":"BC20", "ConditionBrowseBranchName":"Immune System Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"Rare", "ConditionBrowseBranchName":"Rare Diseases" } ] } } } } } }