Nctid:
NCT00000511
Payload:
{"FullStudy"=>{"Rank"=>475098, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"December 08, 2023"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000006973", "ConditionMeshTerm"=>"Hypertension"}, {"ConditionMeshId"=>"D000002318", "ConditionMeshTerm"=>"Cardiovascular Diseases"}, {"ConditionMeshId"=>"D000006331", "ConditionMeshTerm"=>"Heart Diseases"}, {"ConditionMeshId"=>"D000014652", "ConditionMeshTerm"=>"Vascular Diseases"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M9714", "ConditionBrowseLeafName"=>"Hypertension", "ConditionBrowseLeafAsFound"=>"Hypertension", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M9109", "ConditionBrowseLeafName"=>"Heart Diseases", "ConditionBrowseLeafAsFound"=>"Heart Disease", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M17090", "ConditionBrowseLeafName"=>"Vascular Diseases", "ConditionBrowseLeafAsFound"=>"Vascular Disease", "ConditionBrowseLeafRelevance"=>"high"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Heart and Blood Diseases", "ConditionBrowseBranchAbbrev"=>"BC14"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}]}}, "InterventionBrowseModule"=>{"InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M5071", "InterventionBrowseLeafName"=>"Calcium", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"M5088", "InterventionBrowseLeafName"=>"Calcium, Dietary", "InterventionBrowseLeafRelevance"=>"low"}, {"InterventionBrowseLeafId"=>"T415", "InterventionBrowseLeafName"=>"Omega 3 Fatty Acid", "InterventionBrowseLeafAsFound"=>"Geriatric Oncology", "InterventionBrowseLeafRelevance"=>"high"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}, {"InterventionBrowseBranchName"=>"Bone Density Conservation Agents", "InterventionBrowseBranchAbbrev"=>"BDCA"}, {"InterventionBrowseBranchName"=>"Other Dietary Supplements", "InterventionBrowseBranchAbbrev"=>"Ot"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Phase 2"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignAllocation"=>"Randomized", "DesignPrimaryPurpose"=>"Treatment", "DesignInterventionModel"=>"Crossover Assignment"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "StartDateStruct"=>{"StartDate"=>"December 1983"}, "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"December 2013", "CompletionDateStruct"=>{"CompletionDate"=>"November 1994", "CompletionDateType"=>"Actual"}, "LastUpdateSubmitDate"=>"December 12, 2013", "StudyFirstSubmitDate"=>"October 27, 1999", "StudyFirstSubmitQCDate"=>"October 27, 1999", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"December 13, 2013", "LastUpdatePostDateType"=>"Estimate"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"October 28, 1999", "StudyFirstPostDateType"=>"Estimate"}, "PrimaryCompletionDateStruct"=>{"PrimaryCompletionDate"=>"November 1994", "PrimaryCompletionDateType"=>"Actual"}}, "OutcomesModule"=>{"PrimaryOutcomeList"=>{"PrimaryOutcome"=>[{"PrimaryOutcomeMeasure"=>"Blood Pressure", "PrimaryOutcomeTimeFrame"=>"End of study", "PrimaryOutcomeDescription"=>"14 hour ambulatory BP"}]}}, "ConditionsModule"=>{"ConditionList"=>{"Condition"=>["Cardiovascular Diseases", "Heart Diseases", "Hypertension", "Vascular Diseases"]}}, "ReferencesModule"=>{"ReferenceList"=>{"Reference"=>[{"ReferencePMID"=>"8416666", "ReferenceType"=>"background", "ReferenceCitation"=>"Morris MC, Taylor JO, Stampfer MJ, Rosner B, Sacks FM. The effect of fish oil on blood pressure in mild hypertensive subjects: a randomized crossover trial. Am J Clin Nutr. 1993 Jan;57(1):59-64. doi: 10.1093/ajcn/57.1.59."}]}}, "DescriptionModule"=>{"BriefSummary"=>"To test the efficacy of omega-3 fatty acids in untreated mild hypertensives and magnesium, calcium, and potassium supplementation supplementation in non-hypertensives. These clinical trials were conducted in sequence over a four year period.", "DetailedDescription"=>"BACKGROUND:\n\nThe hypothesis that omega-3 fatty acids as well as magnesium and potassium in the diet lowered blood pressure in mild hypertensives needed further documentation, although preliminary and less well controlled studies had suggested such an effect was possible. In a previous study the investigators did not find a hypotensive effect of another polyunsaturated fatty acid, linoleic acid. In addition, findings of lower blood pressures in vegetarians and results obtained from a study in which vegetarian diets were fed to normotensives led to the conclusion that dietary factors other then linoleic acid were responsible for the possible hypotensive effect of vegetarian diets. The nutrients which were selected for further study, omega-3 fatty acids, magnesium and potassium, occur in higher amounts in vegetarian diets.\n\nDietary supplementation with fish oils had only been done in a few studies with inconclusive results. However, the relationship of omega-3 fatty acids to the synthesis of prostacyclins, which are locally active vasodilators and which decrease with the excretion of the vasoconstrictor thromboxane, provide a possible mechanism for an effect of these compounds on blood pressure.\n\nThe role of potassium in the control of blood pressure was first suggested from cross-cultural studies in which populations consuming high levels of potassium displayed lower rates of hypertension and a decrease in blood pressure with age. Cohort studies within this country have also shown a relationship between potassium intake or the ratio of potassium and sodium, as measured by urinary excretion and blood pressure. Most constantly it found that blood pressure differences between blacks and whites have been related to differences in potassium excretion.\n\nThe results from human experimental studies involving potassium supplementation in normotensives and hypertensives have indicated mixed effects but blood pressure lowering was most consistently observed in subgroups with a family history of hypertension or those with higher blood pressure.\n\nDESIGN NARRATIVE:\n\nTrial 1: Subjects were randomized to a fish oil treatment group of 6 or 12 grams/day of omega-3 fatty acids or to a placebo group. At the end of 12 and 24 weeks, participants in the three groups were crossed-over to one of the other two treatments for an additional 12 weeks. The primary outcome was clinic blood pressure on 3 days at the end of the treatment period.\n\nTrial 2: Subjects were randomly assigned to one of four treatments and placebo: magnesium supplementation; potassium supplementation; calcium supplementation; all 3 supplements; matching placebos. The trial was double-blinded. Each of the treatments was administered for six months with measurements taken at baseline and at the end. The primary outcome was 24-hour ambulatory systolic BP.\n\nThe study completion date listed in this record was obtained from the Query/View/Report (QVR) System."}, "EligibilityModule"=>{"Gender"=>"All", "MaximumAge"=>"70 years", "MinimumAge"=>"21 years", "StdAgeList"=>{"StdAge"=>["Adult", "Older Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"Mild hypertensives, ages 21 to 70, with no evidence of end-organ damage.. Untreated hypertensives."}, "IdentificationModule"=>{"NCTId"=>"NCT00000511", "BriefTitle"=>"Polyunsaturates and KCL to Control Mild Hypertension", "Organization"=>{"OrgClass"=>"OTHER", "OrgFullName"=>"Brigham and Women's Hospital"}, "OrgStudyIdInfo"=>{"OrgStudyId"=>"30"}, "SecondaryIdInfoList"=>{"SecondaryIdInfo"=>[{"SecondaryId"=>"R01HL034593", "SecondaryIdLink"=>"https://reporter.nih.gov/quickSearch/R01HL034593", "SecondaryIdType"=>"U.S. NIH Grant/Contract"}, {"SecondaryId"=>"R01HL034593-05", "SecondaryIdLink"=>"https://reporter.nih.gov/quickSearch/R01HL034593-05", "SecondaryIdType"=>"U.S. NIH Grant/Contract"}]}}, "ArmsInterventionsModule"=>{"ArmGroupList"=>{"ArmGroup"=>[{"ArmGroupType"=>"Placebo Comparator", "ArmGroupLabel"=>"Potassium, Magnesium, Calcium, The 3 together, Placebo", "ArmGroupDescription"=>"Parallel study design, 4 treatment groups", "ArmGroupInterventionList"=>{"ArmGroupInterventionName"=>["Dietary Supplement: mineral supplements", "Dietary Supplement: Trial 1: fatty acids, omega-3; Trial 2: Mineral supplements", "Behavioral: dietary supplements"]}}]}, "InterventionList"=>{"Intervention"=>[{"InterventionName"=>"mineral supplements", "InterventionType"=>"Dietary Supplement", "InterventionArmGroupLabelList"=>{"InterventionArmGroupLabel"=>["Potassium, Magnesium, Calcium, The 3 together, Placebo"]}}, {"InterventionName"=>"Trial 1: fatty acids, omega-3; Trial 2: Mineral supplements", "InterventionType"=>"Dietary Supplement", "InterventionArmGroupLabelList"=>{"InterventionArmGroupLabel"=>["Potassium, Magnesium, Calcium, The 3 together, Placebo"]}}, {"InterventionName"=>"dietary supplements", "InterventionType"=>"Behavioral", "InterventionArmGroupLabelList"=>{"InterventionArmGroupLabel"=>["Potassium, Magnesium, Calcium, The 3 together, Placebo"]}}]}}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"Brigham and Women's Hospital", "LeadSponsorClass"=>"OTHER"}, "CollaboratorList"=>{"Collaborator"=>[{"CollaboratorName"=>"National Heart, Lung, and Blood Institute (NHLBI)", "CollaboratorClass"=>"NIH"}]}, "ResponsibleParty"=>{"ResponsiblePartyType"=>"Principal Investigator", "ResponsiblePartyInvestigatorTitle"=>"Professor of Medicine", "ResponsiblePartyInvestigatorFullName"=>"Frank M. Sacks", "ResponsiblePartyInvestigatorAffiliation"=>"Brigham and Women's Hospital"}}}}}}
