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.

What Was Tested

This randomized controlled trial looks at Vitamin D, K2, Magnesium and Zinc.

Preterm birth is the leading cause of infant mortality globally, including Brazil.

ClinicalTrials.gov Identifier NCT02032186, registered December 19, 2013.

Who Took Part

The study group was 2000 women.

The age groups tagged for this paper are infants, teenagers, young adults, adults and middle-aged adults, women only.

The researchers will include women at higher risk for placental dysfunction, based on clinical factors from a prior pregnancy (e.g., prior preterm delivery, stillbirth or preeclampsia) or the current pregnancy (e.g., chronic hypertension, pre-pregnancy diabetes mellitus, maternal age > 35 years or pre-pregnancy maternal body mass index > 30 kg/m2).

How the Study Was Run

In design terms this was a randomized, double-blind, placebo-controlled and multicenter study.

Random assignment meant chance, not the researchers, decided who got Vitamin D, K2, Magnesium and Zinc and who got the comparison, which limits bias.

Blinding on both sides kept the women and researchers unaware of who received Vitamin D, K2, Magnesium and Zinc.

The comparison arm used a placebo, so changes seen with Vitamin D, K2, Magnesium and Zinc could be set against what happens without it.

Running at several centres spread the Vitamin D, K2, Magnesium and Zinc study over different clinics and patient groups.

What Was Measured

Topics PubMed links to this paper include Abruptio Placentae, Brazil, Citric Acid, Dietary Supplements, Infant Death, Infant, Small for Gestational Age and Magnesium Deficiency.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Vitamin D, K2, Magnesium and Zinc in 2000 women.

With several hundred people or more, it is a fairly large study for this kind of research.

Results are reported in around 1 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2014 (BMC pregnancy and childbirth), a journal based in England.

More context: the Vitamin D, K2, Magnesium and Zinc compound page, all human trials.