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Vitamin D Supplementation Among Pregnant Women in Uganda for the Prevention of Hypertensive Disorders in Pregnancy, and Other Adverse Maternal and Foetal Outcomes
Sponsor: St Mary's Hospital, Lacor
Summary
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.
Official title: Vitamin D Supplementation Among Pregnant Women in Uganda and for the Prevention of Adverse Obstetric Outcomes: a Randomized Controlled Trial
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1980
Start Date
2026-06-01
Completion Date
2027-12-31
Last Updated
2026-04-03
Healthy Volunteers
No
Conditions
Interventions
oral 2.000 IU vitamin D3 (cholecalciferol) daily, in addition to routine ANC supplementations
The 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
The placebo will be identical to the intervention, with the exception of Vitamin D3, and will have no known pharmacological or physiological activity