{ "FullStudy":{ "Rank":217546, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01519986", "OrgStudyIdInfo":{ "OrgStudyId":"VITD_100484" }, "Organization":{ "OrgFullName":"Federal University of Rio Grande do Sul", "OrgClass":"OTHER" }, "BriefTitle":"The Effect of Fat on Vitamin D Absorption", "OfficialTitle":"The Effect of Fat on Vitamin D Absorption After a Single Oral Dose", "Acronym":"VITD_100484" }, "StatusModule":{ "StatusVerifiedDate":"January 2012", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"September 2011" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"October 2011", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"October 2011", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 5, 2012", "StudyFirstSubmitQCDate":"January 24, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 27, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"January 24, 2012", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"January 27, 2012", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Principal Investigator", "ResponsiblePartyInvestigatorFullName":"Fabiana Viegas Raimundo", "ResponsiblePartyInvestigatorTitle":"Master Degree", "ResponsiblePartyInvestigatorAffiliation":"Federal University of Rio Grande do Sul" }, "LeadSponsor":{ "LeadSponsorName":"Federal University of Rio Grande do Sul", "LeadSponsorClass":"OTHER" }, "CollaboratorList":{ "Collaborator":[ { "CollaboratorName":"Hospital de Clinicas de Porto Alegre", "CollaboratorClass":"OTHER" },{ "CollaboratorName":"Conselho Nacional de Desenvolvimento Científico e Tecnológico", "CollaboratorClass":"OTHER_GOV" } ] } }, "OversightModule":{ "OversightHasDMC":"Yes" }, "DescriptionModule":{ "BriefSummary":"The purpose of this study is to evaluate the absorption of dietary supplement of vitamin D3 (cholecalciferol), through the variation of 25 (OH) D levels, as the fat content of the meal associated with the administration of the supplement." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Vitamin D Deficiency" ] }, "KeywordList":{ "Keyword":[ "Vitamin D", "Cholecalciferol", "Supplementation", "Dietary Supplements", "Dietary Fats", "25-hydroxyvitamin D" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Not Applicable" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignMaskingInfo":{ "DesignMasking":"Double", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Investigator" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"64", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Low fat Meal", "ArmGroupType":"Experimental", "ArmGroupDescription":"50,000 UI vitamin D3 with low fat meal", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Dietary Supplement: Vitamin D3", "Dietary Supplement: Placebo" ] } },{ "ArmGroupLabel":"Medium fat meal", "ArmGroupType":"Experimental", "ArmGroupDescription":"50,000 UI vitamin D3 with medium fat meal", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Dietary Supplement: Vitamin D3", "Dietary Supplement: Placebo" ] } },{ "ArmGroupLabel":"High fat meal", "ArmGroupType":"Experimental", "ArmGroupDescription":"50,000 UI vitamin D3 with high fat meal", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Dietary Supplement: Vitamin D3", "Dietary Supplement: Placebo" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Dietary Supplement", "InterventionName":"Vitamin D3", "InterventionDescription":"Supplement of vitamin D3", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "High fat meal", "Low fat Meal", "Medium fat meal" ] } },{ "InterventionType":"Dietary Supplement", "InterventionName":"Placebo", "InterventionDescription":"Placebo", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "High fat meal", "Low fat Meal", "Medium fat meal" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Change from baseline in serum 25(OH)D at 14 day after intervention", "PrimaryOutcomeDescription":"25(OH)D response to supplemental vitamin D3", "PrimaryOutcomeTimeFrame":"Change from baseline in serum 25(OH)D at 14 days" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Change from baseline in Parathyroid hormone at 14 days after intervention", "SecondaryOutcomeDescription":"Parathyroid hormone response to supplemental vitamin D3", "SecondaryOutcomeTimeFrame":"Change from baseline in Parathyroid hormone at 14 days" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nResidents of the hospital clinics of Porto Alegre\n\nExclusion Criteria:\n\nDon't drink milk\nObesity\nMalnutrition\nLiver disease\nKidney disease or diabetes\nUse of dietary supplements containing calcium and vitamin D\nMedications\nAnticonvulsants\nBarbiturates, or steroids.\nHaving performed a journey the last four months to locations near the Earth's equatorial plane, due to sun exposure that may have occurred during this period, or vacations planned during the study period.", "HealthyVolunteers":"Accepts Healthy Volunteers", "Gender":"All", "MinimumAge":"18 Years", "MaximumAge":"40 Years", "StdAgeList":{ "StdAge":[ "Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Tania W Furlanetto, PhD", "OverallOfficialAffiliation":"Federal University of Health Science of Porto Alegre", "OverallOfficialRole":"Principal Investigator" },{ "OverallOfficialName":"Gustavo AM Faulhaber, PhD", "OverallOfficialAffiliation":"Federal University of Health Science of Porto Alegre", "OverallOfficialRole":"Study Chair" },{ "OverallOfficialName":"Fabiana V Raimundo, MD", "OverallOfficialAffiliation":"Federal University of Health Science of Porto Alegre", "OverallOfficialRole":"Study Chair" } ] } }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferencePMID":"22190928", "ReferenceType":"background", "ReferenceCitation":"Raimundo FV, Faulhaber GA, Menegatti PK, Marques Lda S, Furlanetto TW. Effect of High- versus Low-Fat Meal on Serum 25-Hydroxyvitamin D Levels after a Single Oral Dose of Vitamin D: A Single-Blind, Parallel, Randomized Trial. Int J Endocrinol. 2011;2011:809069. doi: 10.1155/2011/809069. Epub 2011 Dec 7." },{ "ReferencePMID":"15956", "ReferenceType":"background", "ReferenceCitation":"Avnur Z, Nathan I, Dvilansky A, Livne A. Plasma constituent (s) inhibiting platelet adhesiveness. Isr J Med Sci. 1977 Mar;13(3):264-71." } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000014807", "InterventionMeshTerm":"Vitamin D" },{ "InterventionMeshId":"D000002762", "InterventionMeshTerm":"Cholecalciferol" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000014815", "InterventionAncestorTerm":"Vitamins" },{ "InterventionAncestorId":"D000018977", "InterventionAncestorTerm":"Micronutrients" },{ "InterventionAncestorId":"D000078622", "InterventionAncestorTerm":"Nutrients" },{ "InterventionAncestorId":"D000006133", "InterventionAncestorTerm":"Growth Substances" },{ "InterventionAncestorId":"D000045505", "InterventionAncestorTerm":"Physiological Effects of Drugs" },{ "InterventionAncestorId":"D000050071", "InterventionAncestorTerm":"Bone Density Conservation Agents" },{ "InterventionAncestorId":"D000077264", "InterventionAncestorTerm":"Calcium-Regulating Hormones and Agents" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M16133", "InterventionBrowseLeafName":"Vitamin D", "InterventionBrowseLeafAsFound":"Vitamin D", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M16141", "InterventionBrowseLeafName":"Vitamins", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M4586", "InterventionBrowseLeafName":"Cholecalciferol", "InterventionBrowseLeafAsFound":"Vitamin D3", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M15468", "InterventionBrowseLeafName":"Trace Elements", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M19593", "InterventionBrowseLeafName":"Micronutrients", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M1986", "InterventionBrowseLeafName":"Nutrients", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M3963", "InterventionBrowseLeafName":"Calcium", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M3980", "InterventionBrowseLeafName":"Calcium, Dietary", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M8372", "InterventionBrowseLeafName":"Hormones", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"T440", "InterventionBrowseLeafName":"Calciferol", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"T442", "InterventionBrowseLeafName":"Cholecalciferol", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"T479", "InterventionBrowseLeafName":"Vitamin D3", "InterventionBrowseLeafAsFound":"Vitamin D3", "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" } ] } } } } } }