Vitamin D3 Supplementation Regimens and Preeclampsia Risk (VitD-PE-RCT)

Effect of Different Dosages of Vitamin D3 Supplementation on the Risk of Preeclampsia in Pregnant Women With Vitamin D Deficiency

This study is a randomized controlled trial with two parallel groups connected at Al-Thawra Modern General Hospital in Sana'a, Yemen.

It aims to compara the effect of two different vitamin D3 supplementation regimens during pregnancy on the risk of pre-eclampsia among women with confirmed vitamin D deficiency.

Pregnant women attending antenatal care and diagnosed with vitamin D deficiency will be screened for eligibility. Eligible participants will be randomly assigned to one of two intervention groups:one group receiving vitamin D3 50,000 IU every two weeks and the other group receiving vitamin D3 5,000 IU weekly,in addition to standard antenatal care.

The study will include singleton pregnancies between 8_18 weeks of gestation with serum 25-hydroxyvitamin D level below 25 ng /mL . Women with chronic conditions that may affect pregnancy outcomes or vitamin D metabolism will be excluded. Participants will be followed throughout pregnancy to assess the development of pre-eclampsia and other maternal and fetal outcomes.

Study Overview

• Status: Recruiting
• Conditions: Preeclampsia
• Intervention / Treatment: Dietary supplement: Vitamin D3; Dietary supplement: Vitamin D3

Detailed Description

Vitamin D deficiency during pregnancy has been associated with advers maternal and neonatal outcomes, including an increased risk of preeclampsia.However,the optimal dosage regimen of vitamin D3 supplementation in deficient pregnant women remains uncertain.

This randomized controlled trial will be conducted at Al-Thawra Modern General Hospital in Sana'a, Yemen, and will include pregnant women with confirmed vitamin D deficiency in early pregnancy. Participants will be randomly assigned to one of two vitamin D3 supplementation regimens and followed throughout pregnancy.

The study aims to compare the effectiveness of two different vitamin D3 dosing scheduales in reducing the incidence of preeclampsia.Maternal vitamin D status and pregnancy outcomes will be assessed as secondary measures to evaluate the overall impact of supplementation.

• Study Type: Interventional
• Enrollment (Estimated): 268
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amany Omer Taib, MBBS; Phone Number: +967775851225; Email: a.taib@su.edu.ye

Study Locations

• Yemen
  • Maeen District
    • Sanaa, Maeen District, Yemen
      • Recruiting
      • Faculty of Medicine and Health Sciences, Sana'a University
      • Contact: Amany Omer Taib, MBBS; Phone Number: +967775851225; Email: a.taib@su.edu.ye

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Singleton pregnancy
• Pregnant women between 8 and 18 weeks of gestation
• Serum 25-hydroxyvitamin D [25(OH)D] level < 25 ng/mL
• Willing and able to provide written informed consent
• Planning to receive ongoing antenatal care and deliver at Al-Thawra Modern General Hospital.

Exclusion Criteria:

• Uncontrolled chronic hypertension
• Current use of vitamin D supplementation before enrollment
• Severe chronic kidney disease
• Pre-existing diabetes mellitus
• Autoimmune or immunological disorders
• Known fetal congenital anomalies
• Primary hyperparathyroidism
• Thyroid disease
• Use of medications that affect vitamin D or calcium metabolism
• Inability or unwillingness to comply with the study protocol or follow-up schedule

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1: Vitamin D3 50,000 IU every 2 weeks; Participants in this arm will receive oral vitamin D3 supplementation at a dose of 50,000 IU every 2 weekly in addition to routine antenatal care. Supplementation will continue from enrollment until delivery, and participants will be monitored throughout pregnancy for the development of preeclampsia and other maternal and neonatal outcomes.	Dietary supplement: Vitamin D3; Arm 1: Oral vitamin D3 supplementation administered during pregnancy. Participants will receive : 50,000 IU every two weeks according to their randomized group assignment.; Dietary supplement: Vitamin D3; Oral vitamin D3 supplementation administered during pregnancy. Participants will receive : 5,000 IU every week according to their randomized group assignment.
Experimental: Arm 2 : Vitamin D3 5,000 IU every week; Participants in this arm will receive oral vitamin D3 supplementation at a dose of 5,000 IU once weekly in addition to routine antenatal care. Supplementation will continue from enrollment until delivery, and participants will be monitored throughout pregnancy for the development of preeclampsia and other maternal and neonatal outcomes.	Dietary supplement: Vitamin D3; Arm 1: Oral vitamin D3 supplementation administered during pregnancy. Participants will receive : 50,000 IU every two weeks according to their randomized group assignment.; Dietary supplement: Vitamin D3; Oral vitamin D3 supplementation administered during pregnancy. Participants will receive : 5,000 IU every week according to their randomized group assignment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Pre-eclampsia events	Occurance of preeclampsia during pregnancy , diagnosed according standared clinical criteria including new onset hypertention after 20weeks of gestation with proteinuria or other feature of maternal organ dysfunction.	From 20 weeks of gestation until delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of Preeclampsia	Description Severity of preeclampsia assessed by the need for preterm delivery, maternal intensive care unit admission, or other severe maternal complications.	At diagnosis of preeclampsia until delivery
Gestational Age at Onset of Preeclampsia	Gestational age in weeks at the time of first diagnosis of preeclampsia.	At first diagnosis of preeclampsia
Occurrence of Severe Maternal Complications	Occurrence of HELLP syndrome, eclampsia, or placental abruption during pregnancy	From enrollment until delivery
Incidence of Gestational Diabetes Mellitus	Occurrence of gestational diabetes diagnosed according to standard clinical criteria.	From enrollment until delivery]
Incidence of Gestational Hypertension	Occurrence of gestational hypertension diagnosed according to standard clinical criteria.	From enrollment until delivery
Maternal Mortality	Death of a participant during pregnancy or within 42 days after termination of pregnancy.	From enrollment until 42 days postpartum
Incidence of Low Birth Weight	Proportion of newborns with birth weight less than 2500 grams.	At birth
Incidence of Preterm Birth	Delivery occurring before 37 completed weeks of gestation.	At delivery
Neonatal Intensive Care Admission	Admission of the newborn to a neonatal intensive care unit.	At birth
Mean Birth Weight	Birth weight of newborns measured in grams.	At birth
Neonatal Mortality	Death of a live-born infant during the neonatal period.	From birth to 28 days of life

Collaborators and Investigators

• Sponsor: Sana'a University
• Investigators: Principal Investigator: Amany Omer Taib, MBBS, Faculty of Medicine and Health Sciences, Sana'a University

Study record dates

Study Major Dates

• Study Start (Actual): August 4, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: June 6, 2026
• First Submitted That Met QC Criteria: June 12, 2026
• First Posted (Actual): June 15, 2026

Study Record Updates

• Last Update Posted (Actual): June 15, 2026
• Last Update Submitted That Met QC Criteria: June 12, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Hypertension, Pregnancy-Induced; Pre-Eclampsia; Lipids; Polycyclic Compounds; Steroids; Fused-Ring Compounds; Cholestenes; Cholestanes; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Cholecalciferol
• Other Study ID Numbers: VitD-PE-2024; (26)-12-8 (Other Identifier: Research Ethics Committee-Sana'a University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data(IPD) will not be made publicly available. Data will be used solely for the purposes of this study and related scientific publications.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No