NCT02032186

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Mar 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2013

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 9, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

July 23, 2020

Status Verified

July 1, 2020

Enrollment Period

1.4 years

First QC Date

December 19, 2013

Last Update Submit

July 21, 2020

Conditions

Magnesium DeficiencyPreterm BirthExtreme Immaturity

Keywords

magnesiumprematurity

Outcome Measures

Primary Outcomes (1)

  • Preterm birth

    Delivery before 37 gestational week

    Delivery

Secondary Outcomes (3)

  • Gestational diabetes mellitus

    24th 28th gestational week

  • Pre-eclampsia

    24th to 38th gestational week

  • Low birth weight

    Delivery

Study Arms (2)

Mg++

EXPERIMENTAL

Magnesium Citrate oral supplementation from early pregnancy; 160 mg twice per day.

Drug: Magnesium citrate

Placebo

PLACEBO COMPARATOR

Placebo pills twice per day.

Drug: Magnesium citrate

Interventions

Magnesium citrateDRUG

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.

Also known as: Citrato de Magnésio
Mg++Placebo

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • gestational age before 20th
  • low risk pregnancy

You may not qualify if:

  • high magnesium serum

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto de Medicina Integral Prof Fernando Figueira (IMIP)

Recife, Pernambuco, 50070550, Brazil

Location

Related Publications (3)

  • de Araujo CAL, Ray JG, Figueiroa JN, Alves JG. BRAzil magnesium (BRAMAG) trial: a double-masked randomized clinical trial of oral magnesium supplementation in pregnancy. BMC Pregnancy Childbirth. 2020 Apr 21;20(1):234. doi: 10.1186/s12884-020-02935-7.

    PMID: 32316938DERIVED

  • de Araujo CAL, de Sousa Oliveira L, de Gusmao IMB, Guimaraes A, Ribeiro M, Alves JGB. Magnesium supplementation and preeclampsia in low-income pregnant women - a randomized double-blind clinical trial. BMC Pregnancy Childbirth. 2020 Apr 9;20(1):208. doi: 10.1186/s12884-020-02877-0.

    PMID: 32272914DERIVED

  • Alves JG, de Araujo CA, Pontes IE, Guimaraes AC, Ray JG. The BRAzil MAGnesium (BRAMAG) trial: a randomized clinical trial of oral magnesium supplementation in pregnancy for the prevention of preterm birth and perinatal and maternal morbidity. BMC Pregnancy Childbirth. 2014 Jul 8;14:222. doi: 10.1186/1471-2393-14-222.

    PMID: 25005784DERIVED

MeSH Terms

Conditions

Magnesium DeficiencyPremature Birth

Interventions

magnesium citrate

Condition Hierarchy (Ancestors)

Deficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic DiseasesObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Joao G Alves, PhD

    Instituto de Medicina Integral Prof Fernando Figueira

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Teaching Director

Study Record Dates

First Submitted

December 19, 2013

First Posted

January 9, 2014

Study Start

March 1, 2014

Primary Completion

August 1, 2015

Study Completion

December 1, 2015

Last Updated

July 23, 2020

Record last verified: 2020-07

Locations

BR(1)