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Low Dose Calcium to Prevent Preeclampsia

NCT02338687 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1040

Last updated 2023-10-12

No results posted yet for this study

Summary

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.

Conditions

  • Pre-Eclampsia
  • Hypertension, Pregnancy-Induced
  • Dietary Calcium Deficiency

Interventions

DIETARY_SUPPLEMENT

calcium

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

BEHAVIORAL

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

Sponsors & Collaborators

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

    collaborator UNKNOWN

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

    collaborator UNKNOWN

  • Universidade Federal do Amazonas

    collaborator OTHER

  • Federal University of São Paulo

    lead OTHER

Principal Investigators

  • Maria Regina Torloni, MD, PhD · Sao Paulo Federal University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2018-10-31
Completion
2018-10-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02338687 on ClinicalTrials.gov