Nctid:
NCT00000543
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-21"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000014115", "term"=>"Toxemia"}, {"id"=>"D000004461", "term"=>"Eclampsia"}, {"id"=>"D000011225", "term"=>"Pre-Eclampsia"}, {"id"=>"D000006973", "term"=>"Hypertension"}, {"id"=>"D000002318", "term"=>"Cardiovascular Diseases"}, {"id"=>"D000006331", "term"=>"Heart Diseases"}, {"id"=>"D000014652", "term"=>"Vascular Diseases"}], "ancestors"=>[{"id"=>"D000046110", "term"=>"Hypertension, Pregnancy-Induced"}, {"id"=>"D000011248", "term"=>"Pregnancy Complications"}, {"id"=>"D000005261", "term"=>"Female Urogenital Diseases and Pregnancy Complications"}, {"id"=>"D000091642", "term"=>"Urogenital Diseases"}, {"id"=>"D000007239", "term"=>"Infections"}], "browseLeaves"=>[{"id"=>"M10024", "name"=>"Hypertension", "asFound"=>"Hypertension", "relevance"=>"HIGH"}, {"id"=>"M9419", "name"=>"Heart Diseases", "asFound"=>"Heart Disease", "relevance"=>"HIGH"}, {"id"=>"M20864", "name"=>"Sepsis", "relevance"=>"LOW"}, {"id"=>"M17400", "name"=>"Vascular Diseases", "asFound"=>"Vascular Disease", "relevance"=>"HIGH"}, {"id"=>"M14106", "name"=>"Pre-Eclampsia", "asFound"=>"Pre-Eclampsia", "relevance"=>"HIGH"}, {"id"=>"M16869", "name"=>"Toxemia", "asFound"=>"Toxemia", "relevance"=>"HIGH"}, {"id"=>"M7633", "name"=>"Eclampsia", "asFound"=>"Eclampsia", "relevance"=>"HIGH"}, {"id"=>"M25635", "name"=>"Hypertension, Pregnancy-Induced", "relevance"=>"LOW"}, {"id"=>"M14127", "name"=>"Pregnancy Complications", "relevance"=>"LOW"}, {"id"=>"M2875", "name"=>"Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M27093", "name"=>"Female Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M8399", "name"=>"Female Urogenital Diseases and Pregnancy Complications", "relevance"=>"LOW"}, {"id"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"T2019", "name"=>"Eclampsia", "asFound"=>"Eclampsia", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Heart and Blood Diseases", "abbrev"=>"BC14"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000002118", "term"=>"Calcium"}], "ancestors"=>[{"id"=>"D000077264", "term"=>"Calcium-Regulating Hormones and Agents"}, {"id"=>"D000045505", "term"=>"Physiological Effects of Drugs"}], "browseLeaves"=>[{"id"=>"M5381", "name"=>"Calcium", "asFound"=>"Education", "relevance"=>"HIGH"}, {"id"=>"M5398", "name"=>"Calcium, Dietary", "relevance"=>"LOW"}, {"id"=>"M9789", "name"=>"Hormones", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Bone Density Conservation Agents", "abbrev"=>"BDCA"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"DOUBLE"}, "primaryPurpose"=>"PREVENTION"}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1993-08"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2002-04", "completionDateStruct"=>{"date"=>"1999-07", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2016-05-12", "studyFirstSubmitDate"=>"1999-10-27", "studyFirstSubmitQcDate"=>"1999-10-27", "lastUpdatePostDateStruct"=>{"date"=>"2016-05-13", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"1999-10-28", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"conditions"=>["Cardiovascular Diseases", "Heart Diseases", "Hypertension", "Pre-Eclampsia", "Pregnancy Toxemias", "Vascular Diseases"]}, "referencesModule"=>{"references"=>[{"pmid"=>"8588110", "type"=>"BACKGROUND", "citation"=>"Hojo M, August P. Calcium metabolism in normal and hypertensive pregnancy. Semin Nephrol. 1995 Nov;15(6):504-11."}, {"pmid"=>"10329879", "type"=>"BACKGROUND", "citation"=>"Hojo M, Suthanthiran M, Helseth G, August P. Lymphocyte intracellular free calcium concentration is increased in preeclampsia. Am J Obstet Gynecol. 1999 May;180(5):1209-14. doi: 10.1016/s0002-9378(99)70618-6."}, {"pmid"=>"10694185", "type"=>"BACKGROUND", "citation"=>"Curnow KM, Pham T, August P. The L10F mutation of angiotensinogen is rare in pre-eclampsia. J Hypertens. 2000 Feb;18(2):173-8. doi: 10.1097/00004872-200018020-00007."}]}, "descriptionModule"=>{"briefSummary"=>"To determine of providing calcium supplementation to women with pre-existing hypertension reduces the level of blood pressure, requirement for antihypertensive drugs, and incidence of pre-eclampsia.", "detailedDescription"=>"BACKGROUND:\n\nMaternal and fetal complications are more likely to occur in pregnant women with preexisting hypertension. Alterations in calcium metabolism, the renin angiotensin system, and intracellular free calcium concentration have been identified in this high risk population. The beneficial effects of calcium supplementation on blood pressure and the incidence of superimposed pre-eclampsia may be due to correction of the hormonal and cellular basis for vasoconstriction. The trial sought to prove that oral calcium lowered parathyroid hormone, reduced intracellular free calcium, and decreased vascular endothelin production, resulting in vasodilation and compensatory stimulation of the renin-angiotensin system.\n\nDESIGN NARRATIVE:\n\nRandomized. Double blind. In this observational study, subjects were assigned to two grams of supplemental elemental calcium or to placebo at 13 to 15 weeks gestation. The trial determined the effect of oral calcium supplementation on: the level of blood pressure; the need for antihypertensive drugs; forearm and peripheral vascular resistance; the incidence of maternal complications, including pre-eclampsia and eclampsia; and plasma levels of vitamin D3, ionized calcium, parathyroid, renin activity, angiotensin II, endothelin, nitrate/nitrite, prostacyclins, and intracellular calcium concentrations in lymphocytes and platelets. These variables were measured prior to randomization and every two months throughout pregnancy and the postpartum. Support ended in July 1999.\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"=>{"sex"=>"FEMALE", "stdAges"=>["ADULT"], "maximumAge"=>"40 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Pregnant women with chronic hypertension."}, "identificationModule"=>{"nctId"=>"NCT00000543", "briefTitle"=>"Oral Calcium in Pregnant Women With Hypertension", "organization"=>{"class"=>"NIH", "fullName"=>"National Heart, Lung, and Blood Institute (NHLBI)"}, "orgStudyIdInfo"=>{"id"=>"86"}, "secondaryIdInfos"=>[{"id"=>"R01HL048846", "link"=>"https://reporter.nih.gov/quickSearch/R01HL048846", "type"=>"NIH"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"dietary supplements", "type"=>"BEHAVIORAL"}, {"name"=>"calcium", "type"=>"DRUG"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Heart, Lung, and Blood Institute (NHLBI)", "class"=>"NIH"}}}}
