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Trial NCT00000543

Resource URI: http://static.linkedct.org/resource/trials/NCT00000543
linkedct:brief_title Oral Calcium in Pregnant Women With Hypertension
linkedct:condition <http://static.linkedct.org/resource/condition/10514>
linkedct:condition <http://static.linkedct.org/resource/condition/10555>
linkedct:condition <http://static.linkedct.org/resource/condition/13668>
linkedct:condition <http://static.linkedct.org/resource/condition/2312>
linkedct:condition <http://static.linkedct.org/resource/condition/5702>
linkedct:condition <http://static.linkedct.org/resource/condition/6238>
linkedct:criteria Pregnant women with chronic hypertension.
linkedct:description BACKGROUND: Maternal 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. DESIGN NARRATIVE: Randomized. 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.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Female
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age 40 Years
linkedct:eligibility_minimum_age 18 Years
linkedct:end_date July 1999
linkedct:enrollment 0 (xsd:int)
linkedct:firstreceived_date October 27, 1999
linkedct:id NCT00000543
rdfs:label Trial NCT00000543
linkedct:lastchanged_date June 23, 2005
linkedct:lead_sponsor_agency National Heart, Lung, and Blood Institute (NHLBI)
linkedct:nct_id NCT00000543
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:org_study_id 86
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000543>
linkedct:phase Phase 2
linkedct:reference <http://static.linkedct.org/resource/reference/4477>
linkedct:reference <http://static.linkedct.org/resource/reference/49510>
linkedct:reference <http://static.linkedct.org/resource/reference/6491>
linkedct:source National Heart, Lung, and Blood Institute (NHLBI)
linkedct:start_date August 1993
linkedct:study_design Prevention, Randomized, Double-Blind
linkedct:study_type Interventional
linkedct:summary 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.
rdf:type linkedct:trials
linkedct:verification_date April 2002