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
|Condition or disease||Intervention/treatment||Phase|
|Magnesium Deficiency Preterm Birth Extreme Immaturity||Drug: Magnesium citrate||Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||3000 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
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.
- Preterm birth [ Time Frame: Delivery ]Delivery before 37 gestational week
- Gestational diabetes mellitus [ Time Frame: 24th 28th gestational week ]
- Pre-eclampsia [ Time Frame: 24th to 38th gestational week ]
- Low birth weight [ Time Frame: Delivery ]
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
|Contact: Joao G Alves, PhD||+55 81 email@example.com|
|Instituto de Medicina Integral Prof Fernando Figueira (IMIP)||Recruiting|
|Recife, Pernambuco, Brazil, 50070550|
|Contact: Joao G Alves, PhD +55 81 99746351 firstname.lastname@example.org|
|Sub-Investigator: Joel G Ray, PhD|
|Sub-Investigator: Carla A Leal, MD|
|Sub-Investigator: Angelica Guimaraes, MD|
|Principal Investigator:||Joao G Alves, PhD||Instituto de Medicina Integral Prof Fernando Figueira|