Hypertension Clinical Trial
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.
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.
;
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Prevention
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