Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000543
Status:
COMPLETED
Last Update Posted:
2016-05-13
First Post:
1999-10-27
Brief Title:
Oral Calcium in Pregnant Women With Hypertension
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2002-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed 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 nitratenitrite 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
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 nitratenitrite 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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL048846 | NIH | None | httpsreporternihgovquickSearchR01HL048846 |