Ignite Creation Date:
2024-05-05 @ 9:57 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000534
Status:
COMPLETED
Last Update Posted:
2017-03-13
First Post:
1999-10-27
Brief Title:
Calcium for Pre-Eclampsia Prevention CPEP
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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 2295 or placebo n 2294 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
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 2295 or placebo n 2294 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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: