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Trial NCT00000534

Resource URI: http://static.linkedct.org/resource/trials/NCT00000534
linkedct:brief_title Calcium for Pre-Eclampsia Prevention (CPEP)
linkedct:collaborator_agency <http://static.linkedct.org/resource/collabagency/2560>
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/4245>
linkedct:condition <http://static.linkedct.org/resource/condition/5466>
linkedct:condition <http://static.linkedct.org/resource/condition/5702>
linkedct:condition <http://static.linkedct.org/resource/condition/6238>
linkedct:criteria Nulliparous, normotensive, pregnant women.
linkedct:description BACKGROUND: A considerable body of data has associated lower blood pressures with higher levels of dietary calcium. Epidemiologic studies, laboratory evaluations, and clinical trials have also indicated that the incidence of hypertensive disorders of pregnancy is affected similarly by calcium intake. A meta-analysis of five controlled clinical trials of calcium supplementation in pregnancy suggested a significant reduction in proteinuric pre-eclampsia of 46 percent. Several of the trials, however, suffered from 'pitfalls' in the diagnosis of pre-eclampsia, including lack of blinding, uncertain definition of endpoints, and unknown techniques of measurement. Most trials have not assessed the role of dietary nutrients or the possibility that a subgroup with low baseline urinary calcium may benefit most from calcium supplementation. In no trial has the potential for increased risk of kidney stones in the treatment group been examined systematically. Moreover, the daily schedule for administration of calcium, has generally not been reported. There was a great need, therefore, to evaluate the efficacy of calcium supplementation for the prevention of pre-eclampsia in a large multicenter controlled clinical trial. The trial considered the role of dietary nutrients, establish whether treatment is beneficial only for those with low baseline urinary calcium, conduct systematic surveillance for urolithiasis, and employ standardized terminology, techniques of measurement, and diagnostic criteria. The NHLBI provided funding to NICHD for three years by means of an Intraagency Agreement (Y01HC20154). DESIGN NARRATIVE: Randomized, double-blind, multicenter. Healthy nulliparous patients were randomly assigned to receive either 2 grams of supplemental calcium daily ((n = 2,295) or placebo (n = 2,294) in a double-blind study. Study tablets were administered beginning from 13 to 21 completed weeks of gestation and continued until the termination of pregnancy. Eligible patients entered a run-in period of 6 to 14 days to exclude highly noncompliant subjects. During the run-in, obstetrical ultrasound was performed if it had not been obtained previously, and blood was drawn for serum calcium and creatinine. Follow-up visits were scheduled every four weeks through the 29th week of gestation, then every two weeks through the 35th week, and weekly thereafter. Blood pressure and urine-protein were obtained at each clinic visit, during labor and delivery, and during the first 24 hours postpartum. Primary endpoints included pregnancy-associated hypertension, pregnancy-associated proteinuria, pre-eclampsia, eclampsia, or hypertension. Other endpoints included placental abruption, cerebral hemorrhage or thrombosis, elevated liver enzymes, acute renal failure, and disseminated intravascular coagulation. Surveillance was conducted for renal calculi. Recruitment began in May 1992 and ended in March 1995. Follow-up was completed in October of 1995. Data analysis continued through March 2000 under the NICHD contract N01HD13121.
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 June 2000
linkedct:enrollment 0 (xsd:int)
linkedct:firstreceived_date October 27, 1999
linkedct:id NCT00000534
rdfs:label Trial NCT00000534
linkedct:lastchanged_date June 23, 2005
linkedct:lead_sponsor_agency National Heart, Lung, and Blood Institute (NHLBI)
linkedct:nct_id NCT00000534
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:org_study_id 77
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/10848>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/28955>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/36099>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/45405>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/4998>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000534>
linkedct:phase Phase 3
linkedct:reference <http://static.linkedct.org/resource/reference/5060>
linkedct:reference <http://static.linkedct.org/resource/reference/51159>
linkedct:reference <http://static.linkedct.org/resource/reference/52543>
linkedct:reference <http://static.linkedct.org/resource/reference/53459>
linkedct:reference <http://static.linkedct.org/resource/reference/55323>
linkedct:source National Heart, Lung, and Blood Institute (NHLBI)
linkedct:start_date March 1991
linkedct:study_design Prevention, Double-Blind, Placebo Control
linkedct:study_type Interventional
linkedct:summary To evaluate the efficacy of 2 grams per day of oral calcium supplementation in reducing the combined incidence of hypertensive disorders of pregnancy: pre-eclampsia, eclampsia, and the HELLP Syndrome (hypertension, thrombocytopenia, hemolysis, and abnormal liver function). The National Institute of Child Health and Human Development (NICHD) initiated the trial in 1991, with joint funding provided by the National Heart, Lung, and Blood Institute in fiscal years 1992, 1993, and 1995.
rdf:type linkedct:trials
linkedct:verification_date February 2002