Completed

Oral Calcium in Pregnant Women With Hypertension

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What is being tested

dietary supplements

+ calcium
Behavioral
Drug
Who is being recruted

Cardiovascular Diseases
+3

+ Heart Diseases
+ Hypertension
From 18 to 40 Years
How is the trial designed

Prevention Study

Phase 2
Interventional
Study Start: August 1993

Summary

Principal SponsorNational Heart, Lung, and Blood Institute (NHLBI)
Last updated: May 13, 2016
Sourced from a government-validated database.Claim as a partner
Study start date: August 1, 1993Actual date on which the first participant was enrolled.

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.

Official TitleOral Calcium in Pregnant Women With Hypertension 
Principal SponsorNational Heart, Lung, and Blood Institute (NHLBI)
Last updated: May 13, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
Prevention Study
Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

None (Single-arm trial)
: If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How the interventions assigned to participants is kept confidential
Neither participants nor researchers know who is receiving which treatment. This is the most rigorous way to reduce bias, ensuring that expectations do not influence the results.

Other Ways to Mask Information
Open-label
: Everyone knows which treatment is being given.

Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
FemaleBiological sex of participants that are eligible to enroll.
From 18 to 40 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Cardiovascular Diseases
Heart Diseases
Hypertension
Pre-Eclampsia
Pregnancy Toxemias
Vascular Diseases
Criteria

Pregnant women with chronic hypertension.



Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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CompletedNo study centers