Oral Calcium in Pregnant Women With Hypertension
Primary Purpose
Cardiovascular Diseases, Heart Diseases, Hypertension
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
dietary supplements
calcium
Sponsored by
About this trial
This is an interventional prevention trial for Cardiovascular Diseases
Eligibility Criteria
Pregnant women with chronic hypertension.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00000543
First Posted
October 27, 1999
Last Updated
May 12, 2016
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00000543
Brief Title
Oral Calcium in Pregnant Women With Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
April 2002
Overall Recruitment Status
Completed
Study Start Date
August 1993 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 1999 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
5. Study Description
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, 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Heart Diseases, Hypertension, Pre-Eclampsia, Pregnancy Toxemias, Vascular Diseases
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Masking
Double
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
dietary supplements
Intervention Type
Drug
Intervention Name(s)
calcium
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Pregnant women with chronic hypertension.
12. IPD Sharing Statement
Citations:
PubMed Identifier
8588110
Citation
Hojo M, August P. Calcium metabolism in normal and hypertensive pregnancy. Semin Nephrol. 1995 Nov;15(6):504-11.
Results Reference
background
PubMed Identifier
10329879
Citation
Hojo M, Suthanthiran M, Helseth G, August P. Lymphocyte intracellular free calcium concentration is increased in preeclampsia. Am J Obstet Gynecol. 1999 May;180(5):1209-14. doi: 10.1016/s0002-9378(99)70618-6.
Results Reference
background
PubMed Identifier
10694185
Citation
Curnow KM, Pham T, August P. The L10F mutation of angiotensinogen is rare in pre-eclampsia. J Hypertens. 2000 Feb;18(2):173-8. doi: 10.1097/00004872-200018020-00007.
Results Reference
background
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Oral Calcium in Pregnant Women With Hypertension
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