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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
National Heart, Lung, and Blood Institute (NHLBI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiovascular Diseases

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Pregnant women with chronic hypertension.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    October 27, 1999
    Last Updated
    May 12, 2016
    Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)
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    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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