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
Study ID
NCT07510568
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Eclampsia
  • HELLP Syndrome
  • Preeclampsia

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • oral 2.000 IU vitamin D3 (cholecalciferol) daily, in addition to routine ANC supplementations — DRUG
    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 — OTHER
    The placebo will be identical to the intervention, with the exception of Vitamin D3, and will have no known pharmacological or physiological activity

Study Details

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.

Key Dates

First listed
Apr 3, 2026
Start date
Jun 1, 2026
Status verified
Apr 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
1,980 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Intervention group
    Participants will receive oral 2.000 IU vitamin D daily
  • Placebo Comparator: Control group
    Participants will receive an oral placebo daily

Primary Outcome Measure

The primary outcome will be the occurrence of maternal preeclampsia, eclampsia and HELLP syndrome. [ Time Frame: From enrolment to 6 weeks postpartum ]

Central Contacts

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