Low Dose Calcium to Prevent Preeclampsia

NCT ID: NCT02338687

Last Updated: 2023-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1040 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2018-10-31

Brief Summary

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The purpose of this study is to assess, in pregnant women with calcium-poor diets, what is the effectiveness of low-dose (500 mg/day) calcium supplements associated with an educational intervention, compared to the educational intervention alone, in the prevention of preeclampsia and hypertensive disorders during pregnancy.

Detailed Description

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Conditions

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Pre-Eclampsia Hypertension, Pregnancy-Induced Dietary Calcium Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

cluster randomized
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Education

Educational sessions

Group Type ACTIVE_COMPARATOR

Educational sessions

Intervention Type BEHAVIORAL

Women will participate in at least 2 interactive group educational sessions lasting 30 minutes each. Session content: importance of calcium during pregnancy and how to modify their diets to include calcium-rich foods that are available locally

Education plus supplement

Educational sessions and 500 mg calcium per day

Group Type EXPERIMENTAL

calcium

Intervention Type DIETARY_SUPPLEMENT

one chewable tablet daily, at bedtime, containing 500 mg elemental calcium (1250 mg calcium carbonate)

Educational sessions

Intervention Type BEHAVIORAL

Women will participate in at least 2 interactive group educational sessions lasting 30 minutes each. Session content: importance of calcium during pregnancy and how to modify their diets to include calcium-rich foods that are available locally

Interventions

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calcium

one chewable tablet daily, at bedtime, containing 500 mg elemental calcium (1250 mg calcium carbonate)

Intervention Type DIETARY_SUPPLEMENT

Educational sessions

Women will participate in at least 2 interactive group educational sessions lasting 30 minutes each. Session content: importance of calcium during pregnancy and how to modify their diets to include calcium-rich foods that are available locally

Intervention Type BEHAVIORAL

Other Intervention Names

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Dietary counseling

Eligibility Criteria

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Inclusion Criteria

* Capacity to understand verbal and visual instructions
* Gestational age 16 - 20 weeks
* Live fetus

Exclusion Criteria

* Hyperparathyroidism or other contra-indication to calcium supplementation
* Gastrointestinal diseases or conditions that may interfere with calcium absorption (e.g. bariatric surgery, cancer, chronic colitis)
* Use of medications that may interfere with calcium absorption (e.g. corticosteroids, thiazides, thyroid hormones)
* Women already taking calcium supplements or daily antacids at recruitment
Minimum Eligible Age

10 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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PPSUS (Programa Pesquisa para o SUS: gestão compartilhada em saúde)

UNKNOWN

Sponsor Role collaborator

FAPEAM (Fundação de Amparo a Pesquisa do Estado do Amazonas)

UNKNOWN

Sponsor Role collaborator

Universidade Federal do Amazonas

OTHER

Sponsor Role collaborator

Federal University of São Paulo

OTHER

Sponsor Role lead

Responsible Party

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Maria Regina Torloni

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maria Regina Torloni, MD, PhD

Role: STUDY_CHAIR

Sao Paulo Federal University

Locations

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Universidade Federal do Amazonas

Manaus, Amazonas, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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528759

Identifier Type: -

Identifier Source: org_study_id

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