Clinical Trial: Calcium for Pre-Eclampsia Prevention (CPEP)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title:

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 Summary:

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
Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Current Primary Outcome:

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Dates:
Date Received: October 27, 1999
Date Started: March 1991
Date Completion: June 2000
Last Updated: March 9, 2017
Last Verified: March 2017