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Calcium for Pre-Eclampsia Prevention (CPEP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00000534
Recruitment Status : Completed
First Posted : October 28, 1999
Last Update Posted : March 13, 2017
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

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.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Eclampsia Heart Diseases HELLP Syndrome Hypertension Pre-Eclampsia Pregnancy Toxemias Vascular Diseases Drug: calcium Behavioral: dietary supplements Phase 3

Detailed Description:


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).


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.

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Study Type : Interventional  (Clinical Trial)
Masking: Double
Primary Purpose: Prevention
Study Start Date : March 1991
Study Completion Date : June 2000

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Nulliparous, normotensive, pregnant women.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00000534

Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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OverallOfficial: Patrick Catalano Case Western Reserve University
OverallOfficial: Luis Curet University of New Mexico
OverallOfficial: John Hauth University of Alabama at Birmingham
OverallOfficial: Cynthia Morris Oregon Health and Science University
OverallOfficial: Baha Sibai University of Tennessee
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Responsible Party: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Identifier: NCT00000534    
Other Study ID Numbers: 77
First Posted: October 28, 1999    Key Record Dates
Last Update Posted: March 13, 2017
Last Verified: March 2017
Additional relevant MeSH terms:
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HELLP Syndrome
Cardiovascular Diseases
Heart Diseases
Vascular Diseases
Hypertension, Pregnancy-Induced
Pregnancy Complications
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs