Calcium for Pre-Eclampsia Prevention (CPEP)

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00000534
First received: October 27, 1999
Last updated: June 23, 2005
Last verified: February 2002
  Purpose

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

Study Type: Interventional
Study Design: Masking: Double-Blind
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: March 1991
Estimated Study Completion Date: June 2000
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 = 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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Nulliparous, normotensive, pregnant women.

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00000534

Sponsors and Collaborators
Investigators
Investigator: Patrick Catalano Case Western Reserve University
Investigator: Luis Curet University of New Mexico
Investigator: John Hauth University of Alabama at Birmingham
Investigator: Cynthia Morris Oregon Health and Science University
Investigator: Baha Sibai University of Tennessee
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00000534     History of Changes
Other Study ID Numbers: 77
Study First Received: October 27, 1999
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
Hypertension
Vascular Diseases
Eclampsia
Pre-Eclampsia
HELLP Syndrome
Hypertension, Pregnancy-Induced
Pregnancy Complications

ClinicalTrials.gov processed this record on September 22, 2014