The goal of this randomised controlled trial is to investigate if vitamin D supplementation among pregnant women in Uganda prevents adverse maternal and foetal outcomes, with special emphasis on preeclampsia.
The main question it aims to answer is if Vitamin D supplementation, administered as oral vitamin D₃ at a dose of 2,000 IU once daily, from the time of recruitment to the time of delivery, reduces the incidence of preeclampsia, eclampsia and HELLP syndrome in pregnant women attending ANC at St. Mary's Hospital, Lacor, such incidence being monitored up to six (6) weeks after delivery.
Researchers will compare the effect of oral 2.000 IU vitamin D daily (intervention group) vs. oral placebo daily (control group) on the prevalence of adverse maternal and foetal outcomes.
with a viable intrauterine pregnancy,
at gestational age at recruitment between 13 weeks 0 days and 27 weeks 6 days, and
who consented to participate in the study.
women already on Vitamin D treatment prescribed by a physician.
Parallel
oral 2.000 IU vitamin D3 (cholecalciferol) daily, in addition to routine ANC supplementations
DrugThe intervention group will comprise pregnant women attending ANC at St. Mary's Hospital, Lacor included in the study, who will be randomized to receive daily oral 2,000 IU Vitamin D3, from the recruitment to the delivery. Eligible participants will be women of age ≥ 18 years, who consented to participate in the study, with a viable intrauterine pregnancy, and at gestational age at recruitment between 13 weeks 0 days and 27 weeks 6 days.
Placebo
Other interventionThe placebo will be identical to the intervention, with the exception of Vitamin D3, and will have no known pharmacological or physiological activity
The primary outcome will be the occurrence of maternal preeclampsia, eclampsia and HELLP syndrome.
For each participant, the first occurrence of preeclampsia, eclampsia, or HELLP syndrome during pregnancy will be considered for the primary analysis. The criteria for preeclampsia, eclampsia, or HELLP syndrome are reported in the Operational Definitions of the Study Protocol
The occurrence of maternal Gestational Hypertension (GH)
The criteria for GH are defined in the Operational Definitions of the Study Protocol
Fatal outcome of delivery (live birth or stillbirth), with APGAR score at 1 and 5 minutes
APGAR score is a widely known and standardized tool to asses the clinical conditions of a new-born immediately after birth, and will be measured at 1 minute and 5 minutes after birth.
Preterm birth, i.e., Gestational Age at delivery < 37 weeks
Weeks; the determination of the Gestational Age id defined in the Study Protocol
Mode of delivery
By vaginal delivery or by Caesarean Section
Click on the lead sponsor to view all of their trials.
St Mary's Hospital, Lacor
Lead sponsor
University of Naples
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
