Hypertension Clinical Trial
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.
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.
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