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A Randomized Clinical Trial of Oral Magnesium Supplementation in Pregnancy

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ClinicalTrials.gov Identifier: NCT02032186
Recruitment Status : Unknown
Verified March 2015 by João Guilherme Bezerra Alves, Professor Fernando Figueira Integral Medicine Institute.
Recruitment status was:  Recruiting
First Posted : January 9, 2014
Last Update Posted : March 11, 2015
Sponsor:
Information provided by (Responsible Party):
João Guilherme Bezerra Alves, Professor Fernando Figueira Integral Medicine Institute

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.

Condition or disease Intervention/treatment Phase
Magnesium Deficiency Preterm Birth Extreme Immaturity Drug: Magnesium citrate Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: A Randomized Clinical Trial of Oral Magnesium Supplementation In Pregnancy for the Prevention of Preterm Birth and Perinatal and Maternal Morbidity
Study Start Date : March 2014
Estimated Primary Completion Date : August 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mg++
Magnesium Citrate oral supplementation from early pregnancy; 160 mg twice per day.
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.
Other Name: Citrato de Magnésio

Placebo Comparator: Placebo
Placebo pills twice per day.



Primary Outcome Measures :
  1. Preterm birth [ Time Frame: Delivery ]
    Delivery before 37 gestational week


Secondary Outcome Measures :
  1. Gestational diabetes mellitus [ Time Frame: 24th 28th gestational week ]
  2. Pre-eclampsia [ Time Frame: 24th to 38th gestational week ]
  3. Low birth weight [ Time Frame: Delivery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • gestational age before 20th
  • low risk pregnancy

Exclusion Criteria:

  • high magnesium serum

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02032186


Contacts
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Contact: Joao G Alves, PhD +55 81 99746351 joaoguilherme@imip.org.br

Locations
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Brazil
Instituto de Medicina Integral Prof Fernando Figueira (IMIP) Recruiting
Recife, Pernambuco, Brazil, 50070550
Contact: Joao G Alves, PhD    +55 81 99746351    joaoguilherme@imip.ortg.br   
Sub-Investigator: Joel G Ray, PhD         
Sub-Investigator: Carla A Leal, MD         
Sub-Investigator: Angelica Guimaraes, MD         
Sponsors and Collaborators
Professor Fernando Figueira Integral Medicine Institute
Investigators
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Principal Investigator: Joao G Alves, PhD Instituto de Medicina Integral Prof Fernando Figueira

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: João Guilherme Bezerra Alves, Teaching Director, Professor Fernando Figueira Integral Medicine Institute
ClinicalTrials.gov Identifier: NCT02032186     History of Changes
Other Study ID Numbers: IMIPBMGF
20138 ( Other Grant/Funding Number: CNPq401609 )
First Posted: January 9, 2014    Key Record Dates
Last Update Posted: March 11, 2015
Last Verified: March 2015
Keywords provided by João Guilherme Bezerra Alves, Professor Fernando Figueira Integral Medicine Institute:
magnesium
prematurity
Additional relevant MeSH terms:
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Premature Birth
Magnesium Deficiency
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Deficiency Diseases
Malnutrition
Nutrition Disorders
Magnesium citrate
Citric Acid
Sodium Citrate
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Cathartics
Gastrointestinal Agents