Project description

ABSTRACT
Introduction: The vitamin D recommended doses
during pregnancy differ between societies. The WHO
guidelines do not recommend routine prenatal
supplementation, but they underscore the fact that
women with the lowest levels may benefit most. 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. Our hypothesis is that
in Middle Eastern pregnant women, a vitamin D dose
of 3000 IU/day is required to reach a desirable
maternal 25-hydroxyvitamin D [25(OH)D] level, and to
positively impact infant bone mineral content (BMC).
Methods and analysis: This is a multicentre blinded
randomised controlled trial. Pregnant women
presenting to the Obstetrics and Gynaecology clinics
will be approached. Eligible women will be randomised
to daily equivalent doses of cholecalciferol, 600 IU or
3000 IU, from 15 to 18 weeks gestation until delivery.
Maternal 25(OH)D and chemistries will be assessed at
study entry, during the third trimester and at delivery.
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. A sample size of 280 pregnant women is
needed to demonstrate a statistically significant
difference in the proportion of women reaching a 25
(OH)D level ≥50 nmol/L at delivery, and a difference in
infant BMC of 6 (10)g, for a 90% power and a 2.5%
level of significance. The proportions of women
achieving a target 25(OH)D level will be compared
between the two arms, using χ2
. An independent t test
will be used to compare mean infant BMC between the
two arms. The primary analysis is an intention-to-treat
analysis of unadjusted results.

Researchers

Keywords

Women