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Oral Calcium in Pregnant Women With Hypertension

National Institutes of Health (NIH) logo

National Institutes of Health (NIH)

Status and phase

Completed
Phase 2

Conditions

Pre-Eclampsia
Hypertension
Cardiovascular Diseases
Vascular Diseases
Heart Diseases
Pregnancy Toxemias

Treatments

Drug: calcium
Behavioral: dietary supplements

Study type

Interventional

Funder types

NIH

Identifiers

NCT00000543
R01HL048846 (U.S. NIH Grant/Contract)
86

Details and patient eligibility

About

To determine of providing calcium supplementation to women with pre-existing hypertension reduces the level of blood pressure, requirement for antihypertensive drugs, and incidence of pre-eclampsia.

Full description

BACKGROUND:

Maternal and fetal complications are more likely to occur in pregnant women with preexisting hypertension. Alterations in calcium metabolism, the renin angiotensin system, and intracellular free calcium concentration have been identified in this high risk population. The beneficial effects of calcium supplementation on blood pressure and the incidence of superimposed pre-eclampsia may be due to correction of the hormonal and cellular basis for vasoconstriction. The trial sought to prove that oral calcium lowered parathyroid hormone, reduced intracellular free calcium, and decreased vascular endothelin production, resulting in vasodilation and compensatory stimulation of the renin-angiotensin system.

DESIGN NARRATIVE:

Randomized. Double blind. In this observational study, subjects were assigned to two grams of supplemental elemental calcium or to placebo at 13 to 15 weeks gestation. The trial determined the effect of oral calcium supplementation on: the level of blood pressure; the need for antihypertensive drugs; forearm and peripheral vascular resistance; the incidence of maternal complications, including pre-eclampsia and eclampsia; and plasma levels of vitamin D3, ionized calcium, parathyroid, renin activity, angiotensin II, endothelin, nitrate/nitrite, prostacyclins, and intracellular calcium concentrations in lymphocytes and platelets. These variables were measured prior to randomization and every two months throughout pregnancy and the postpartum. Support ended in July 1999.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Sex

Female

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Pregnant women with chronic hypertension.

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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