Nctid:
NCT00000613
Payload:
{"FullStudy"=>{"Rank"=>474996, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"December 08, 2023"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000010024", "ConditionMeshTerm"=>"Osteoporosis"}, {"ConditionMeshId"=>"D000001847", "ConditionMeshTerm"=>"Bone Diseases"}, {"ConditionMeshId"=>"D000002318", "ConditionMeshTerm"=>"Cardiovascular Diseases"}, {"ConditionMeshId"=>"D000006331", "ConditionMeshTerm"=>"Heart Diseases"}, {"ConditionMeshId"=>"D000003327", "ConditionMeshTerm"=>"Coronary Disease"}, {"ConditionMeshId"=>"D000017202", "ConditionMeshTerm"=>"Myocardial Ischemia"}, {"ConditionMeshId"=>"D000007511", "ConditionMeshTerm"=>"Ischemia"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000010335", "ConditionAncestorTerm"=>"Pathologic Processes"}, {"ConditionAncestorId"=>"D000001851", "ConditionAncestorTerm"=>"Bone Diseases, Metabolic"}, {"ConditionAncestorId"=>"D000009140", "ConditionAncestorTerm"=>"Musculoskeletal Diseases"}, {"ConditionAncestorId"=>"D000008659", "ConditionAncestorTerm"=>"Metabolic Diseases"}, {"ConditionAncestorId"=>"D000014652", "ConditionAncestorTerm"=>"Vascular Diseases"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M6236", "ConditionBrowseLeafName"=>"Coronary Artery Disease", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M6748", "ConditionBrowseLeafName"=>"Depression", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M6751", "ConditionBrowseLeafName"=>"Depressive Disorder", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M10233", "ConditionBrowseLeafName"=>"Ischemia", "ConditionBrowseLeafAsFound"=>"Ischemia", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M19196", "ConditionBrowseLeafName"=>"Myocardial Ischemia", "ConditionBrowseLeafAsFound"=>"Myocardial Ischemia", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M6239", "ConditionBrowseLeafName"=>"Coronary Disease", "ConditionBrowseLeafAsFound"=>"Coronary Disease", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M12637", "ConditionBrowseLeafName"=>"Osteoporosis", "ConditionBrowseLeafAsFound"=>"Osteoporosis", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M9109", "ConditionBrowseLeafName"=>"Heart Diseases", "ConditionBrowseLeafAsFound"=>"Heart Disease", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M4816", "ConditionBrowseLeafName"=>"Bone Diseases", "ConditionBrowseLeafAsFound"=>"Bone Disease", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M4820", "ConditionBrowseLeafName"=>"Bone Diseases, Metabolic", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M11787", "ConditionBrowseLeafName"=>"Musculoskeletal Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M11329", "ConditionBrowseLeafName"=>"Metabolic Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M17090", "ConditionBrowseLeafName"=>"Vascular Diseases", "ConditionBrowseLeafRelevance"=>"low"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Heart and Blood Diseases", "ConditionBrowseBranchAbbrev"=>"BC14"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}, {"ConditionBrowseBranchName"=>"Behaviors and Mental Disorders", "ConditionBrowseBranchAbbrev"=>"BXM"}, {"ConditionBrowseBranchName"=>"Symptoms and General Pathology", "ConditionBrowseBranchAbbrev"=>"BC23"}, {"ConditionBrowseBranchName"=>"Musculoskeletal Diseases", "ConditionBrowseBranchAbbrev"=>"BC05"}, {"ConditionBrowseBranchName"=>"Nutritional and Metabolic Diseases", "ConditionBrowseBranchAbbrev"=>"BC18"}]}}, "InterventionBrowseModule"=>{"InterventionMeshList"=>{"InterventionMesh"=>[{"InterventionMeshId"=>"D000019833", "InterventionMeshTerm"=>"Genistein"}]}, "InterventionAncestorList"=>{"InterventionAncestor"=>[{"InterventionAncestorId"=>"D000016588", "InterventionAncestorTerm"=>"Anticarcinogenic Agents"}, {"InterventionAncestorId"=>"D000020011", "InterventionAncestorTerm"=>"Protective Agents"}, {"InterventionAncestorId"=>"D000045505", "InterventionAncestorTerm"=>"Physiological Effects of Drugs"}, {"InterventionAncestorId"=>"D000000970", "InterventionAncestorTerm"=>"Antineoplastic Agents"}, {"InterventionAncestorId"=>"D000047428", "InterventionAncestorTerm"=>"Protein Kinase Inhibitors"}, {"InterventionAncestorId"=>"D000004791", "InterventionAncestorTerm"=>"Enzyme Inhibitors"}, {"InterventionAncestorId"=>"D000045504", "InterventionAncestorTerm"=>"Molecular Mechanisms of Pharmacological Action"}, {"InterventionAncestorId"=>"D000048789", "InterventionAncestorTerm"=>"Phytoestrogens"}, {"InterventionAncestorId"=>"D000004968", "InterventionAncestorTerm"=>"Estrogens, Non-Steroidal"}, {"InterventionAncestorId"=>"D000004967", "InterventionAncestorTerm"=>"Estrogens"}, {"InterventionAncestorId"=>"D000006728", "InterventionAncestorTerm"=>"Hormones"}, {"InterventionAncestorId"=>"D000006730", "InterventionAncestorTerm"=>"Hormones, Hormone Substitutes, and Hormone Antagonists"}]}, "InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M25685", "InterventionBrowseLeafName"=>"Phytoestrogens", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M21411", "InterventionBrowseLeafName"=>"Genistein", "InterventionBrowseLeafAsFound"=>"D-dimer", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M21559", "InterventionBrowseLeafName"=>"Protective Agents", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M25510", "InterventionBrowseLeafName"=>"Protein Kinase Inhibitors", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M7641", "InterventionBrowseLeafName"=>"Enzyme Inhibitors", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M7806", "InterventionBrowseLeafName"=>"Estrogens", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M9479", "InterventionBrowseLeafName"=>"Hormones", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M9478", "InterventionBrowseLeafName"=>"Hormone Antagonists", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"T294", "InterventionBrowseLeafName"=>"Soy Bean", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}, {"InterventionBrowseBranchName"=>"Antineoplastic Agents", "InterventionBrowseBranchAbbrev"=>"ANeo"}, {"InterventionBrowseBranchName"=>"Herbal and Botanical", "InterventionBrowseBranchAbbrev"=>"HB"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Phase 2"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignAllocation"=>"Randomized", "DesignMaskingInfo"=>{"DesignMasking"=>"Double"}, "DesignPrimaryPurpose"=>"Prevention"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "StartDateStruct"=>{"StartDate"=>"April 1997"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"December 2005", "CompletionDateStruct"=>{"CompletionDate"=>"December 2004", "CompletionDateType"=>"Actual"}, "LastUpdateSubmitDate"=>"February 26, 2016", "StudyFirstSubmitDate"=>"October 27, 1999", "StudyFirstSubmitQCDate"=>"October 27, 1999", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"February 29, 2016", "LastUpdatePostDateType"=>"Estimate"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"October 28, 1999", "StudyFirstPostDateType"=>"Estimate"}}, "ConditionsModule"=>{"ConditionList"=>{"Condition"=>["Bone Diseases", "Cardiovascular Diseases", "Coronary Disease", "Depression", "Heart Diseases", "Myocardial Ischemia", "Osteoporosis", "Postmenopause"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferencePMID"=>"11285326", "ReferenceType"=>"background", "ReferenceCitation"=>"Goodman-Gruen D, Kritz-Silverstein D. Usual dietary isoflavone intake is associated with cardiovascular disease risk factors in postmenopausal women. J Nutr. 2001 Apr;131(4):1202-6. doi: 10.1093/jn/131.4.1202."}, {"ReferencePMID"=>"11860727", "ReferenceType"=>"background", "ReferenceCitation"=>"Kritz-Silverstein D, Goodman-Gruen DL. Usual dietary isoflavone intake, bone mineral density, and bone metabolism in postmenopausal women. J Womens Health Gend Based Med. 2002 Jan-Feb;11(1):69-78. doi: 10.1089/152460902753473480."}, {"ReferencePMID"=>"14501604", "ReferenceType"=>"background", "ReferenceCitation"=>"Goodman-Gruen D, Kritz-Silverstein D. Usual dietary isoflavone intake and body composition in postmenopausal women. Menopause. 2003 Sep-Oct;10(5):427-32. doi: 10.1097/01.GME.0000058866.35869.B4."}]}}, "DescriptionModule"=>{"BriefSummary"=>"To determine the acceptability and benefits of use of a dietary supplement of the phytoestrogen, genistein, versus placebo on heart disease risk factors, bone density, and psychosocial outcomes in postmenopausal women.", "DetailedDescription"=>"BACKGROUND:\n\nEstrogen replacement therapy is beneficial for heart disease risk factors as well as for bone density. However, a large proportion of postmenopausal women are not compliant with therapeutic regimens. Phytoestrogens are naturally occurring compounds found in plants and soy products that have estrogenic effects, and may represent an alternative treatment for the prevention of heart disease and osteoporosis in postmenopausal women. However, few intervention trials have examined the extent to which it is possible to improve heart disease risk factors, bone density, and quality of life in postmenopausal women through use of a dietary supplement of phytoestrogen.\n\nDESIGN NARRATIVE:\n\nRandomized, double-blind, placebo-controlled study. A total of 210 women were enrolled in the study to be followed for one to two years. The women were randomized to phytoestrogen treatment or to placebo. Data are collected at baseline visits, at one and three month follow-up telephone calls, and at 6, 12, and 24 month follow-up clinic visits. Measures of high density lipoprotein and other heart disease risk factors, hip and spine bone density, and depression, life satisfaction, and quality of well-being are obtained. Cross-sectional and longitudinal comparisons of treatment and placebo groups are performed before and after adjustment and stratification for potentially confounding covariates.\n\nThe study was renewed in March 2002 to assess whether the women treated with phytoestrogens had lowered homocysteine, interleukin-6, C-reactive protein, E-selectin, and decreased obesity and fat mass over two years.\n\nThe study completion date listed in this record was obtained from the \"End Date\" entered in the Protocol Registration and Results System (PRS) record."}, "EligibilityModule"=>{"Gender"=>"Female", "MaximumAge"=>"74 years", "MinimumAge"=>"45 years", "StdAgeList"=>{"StdAge"=>["Adult", "Older Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"Postmenopausal women, ages 45 to 74."}, "IdentificationModule"=>{"NCTId"=>"NCT00000613", "BriefTitle"=>"CVD Risk and Health in Postmenopausal Phytoestrogen Users", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Heart, Lung, and Blood Institute (NHLBI)"}, "OrgStudyIdInfo"=>{"OrgStudyId"=>"116"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"R01HL057790", "SecondaryIdLink"=>"https://reporter.nih.gov/quickSearch/R01HL057790", "SecondaryIdType"=>"U.S. NIH Grant/Contract"}]}}, "ArmsInterventionsModule"=>{"InterventionList"=>{"Intervention"=>[{"InterventionName"=>"dietary supplements", "InterventionType"=>"Behavioral"}, {"InterventionName"=>"genistein", "InterventionType"=>"Drug"}, {"InterventionName"=>"diet, soy proteins", "InterventionType"=>"Behavioral"}]}}, "ContactsLocationsModule"=>{"OverallOfficialList"=>{"OverallOfficial"=>[{"OverallOfficialName"=>"Donna Kritz-Silverstein", "OverallOfficialAffiliation"=>"University of California, San Diego"}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"National Heart, Lung, and Blood Institute (NHLBI)", "LeadSponsorClass"=>"NIH"}}}}}}
