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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

NCT07510568 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1980

Last updated 2026-04-03

No results posted yet for this study

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.

Conditions

Interventions

DRUG

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.

OTHER

Placebo

The placebo will be identical to the intervention, with the exception of Vitamin D3, and will have no known pharmacological or physiological activity

Sponsors & Collaborators

  • University of Naples

    collaborator OTHER

  • St Mary's Hospital, Lacor

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2027-12-31
Completion
2027-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07510568 on ClinicalTrials.gov