Effect of vitamin D replacement on maternal and neonatal outcomes: a randomised controlled trial in pregnant women with hypovitaminosis D. A protocol.

What Was Tested

Researchers studied Vitamin D, K2, Magnesium and Zinc in this randomized controlled trial publication.

An independent t test will be used to compare mean infant BMC between the two arms.

Why It Was Studied

The effects of routine supplementation during pregnancy on maternal and neonatal clinical outcomes have not been investigated in the Middle East, where hypovitaminosis D is prevalent.

The protocol has been approved by the Institutional Review Board at the American University of Beirut-Lebanon (IM.GEHF.22).

Who Took Part

The study group was 280 women.

By PubMed's age tags, the people studied were infants, teenagers, young adults, adults and middle-aged adults, women only.

Pregnant women presenting to the Obstetrics and Gynaecology clinics will be approached.

Neonatal anthropometric variables and 25(OH)D level will be measured at birth, and bone and fat mass assessment by dual-energy X-ray absorptiometry scan at 1 month.

How the Study Was Run

The researchers set it up as a randomized, double-blind 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.

As a double-blind Vitamin D, K2, Magnesium and Zinc study, the assignments were hidden from both participants and investigators until the end.

More than one site took part, so the women came from several places.

This is a multicentre blinded randomised controlled trial.

Maternal 25(OH)D and chemistries will be assessed at study entry, during the third trimester and at delivery.

The proportions of women achieving a target 25(OH)D level will be compared between the two arms, using χ(2).

The primary analysis is an intention-to-treat analysis of unadjusted results.

What Was Measured

The effects of routine supplementation during pregnancy on maternal and neonatal clinical outcomes have not been investigated in the Middle East, where hypovitaminosis D is prevalent.

PubMed files the paper under topics including Absorptiometry, Photon, Bone Density, Cholecalciferol, Dietary Supplements, Lebanon, Pregnancy Complications and Vitamin D.

Author keywords: Bone mineral density, Middle East and Neonate.

What This Means in Plain Language

The paper is a randomized, double-blind and multicenter study of Vitamin D, K2, Magnesium and Zinc in 280 women.

The publication is from 2016 (BMJ open), a journal based in England.

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