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A Randomized Clinical Trial of Oral Magnesium Supplementation in Pregnancy

NCT02032186 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3000

Last updated 2020-07-23

No results posted yet for this study

Summary

The investigators propose a preventive strategy that may reduce the risk of placental vascular disease and its negative consequences for both the fetus (e.g., poor fetal growth or stillbirth)and mother (e.g., the hypertensive disorders of pregnancy), and which, in turn, should reduce the need for indicated preterm delivery. This strategy is a multicenter, randomized double-blind, placebo-controlled clinical trial (RCT) comparing magnesium citrate supplementation with placebo, each starting at 12 to 20 weeks gestation and continued until delivery. Magnesium citrate is a safe and inexpensive compound that is easily absorbed by the intestinal tract. The results of this RCT may be especially relevant in low and middle income countries that have high rates of prematurity, and limited resources for acute newborn and maternal care.

Conditions

Interventions

DRUG

Magnesium citrate

Oral Mg++citrate, 160 mg twice daily. Each capsule will contained 160 mg of elemental magnesium citrate. The participants will be instructed to take one capsule twice daily until delivery.

Sponsors & Collaborators

  • Professor Fernando Figueira Integral Medicine Institute

    lead OTHER

Principal Investigators

  • Joao G Alves, PhD · Instituto de Medicina Integral Prof Fernando Figueira

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2015-08-31
Completion
2015-12-31

Countries

  • Brazil

Study Locations

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Entities

Diseases

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 NCT02032186 on ClinicalTrials.gov