Vitamin D3 Supplementation Regimens and Preeclampsia Risk

NCT07648706 | Recruiting

• 2 other identifiers: VitD-PE-2024(26)-12-8
• Study Type: interventional
• Target: 268
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Preeclampsia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Severity of Preeclampsia

  At diagnosis of preeclampsia until delivery

• Gestational Age at Onset of Preeclampsia

  At first diagnosis of preeclampsia

• Occurrence of Severe Maternal Complications

  From enrollment until delivery

• Incidence of Gestational Diabetes Mellitus

  From enrollment until delivery]

• Incidence of Gestational Hypertension

  From enrollment until delivery

Study Arms (2)

Arm 1: Vitamin D3 50,000 IU every 2 weeks

EXPERIMENTAL

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 2 : Vitamin D3 5,000 IU every week

EXPERIMENTAL

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

Interventions

Vitamin D3 DIETARY_SUPPLEMENT

Arm 1: Oral vitamin D3 supplementation administered during pregnancy. Participants will receive : 50,000 IU every two weeks according to their randomized group assignment.

Arm 1: Vitamin D3 50,000 IU every 2 weeks

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sana'a University: lead

Study Sites (1)

Faculty of Medicine and Health Sciences, Sana'a University

Sanaa, Maeen District, Yemen

RECRUITING

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Amany Omer Taib, MBBS

  Faculty of Medicine and Health Sciences, Sana'a University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amany Omer Taib, MBBS

CONTACT

+967775851225; a.taib@su.edu.ye

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No additional masking beyond those specified.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Doctor - Obstetrics & Gynecology

Model Details: Participants will be randomly assigned in a 1:1 ratio to one of two parallel intervention arms .Each arm will recive a different vitamin D3 supplementation regimen during pregnancy .Participants will remain in their assigned group throughout the study period until completion of follow-up Arm 1: Name: Vitamin D3 50,000 IU every 2 weeks Type: Experimental Intervention: Vitamin D3 Arm 2: Name: Vitamin D3 5,000 IU weekly Type: Experimental Intervention: Vitamin D3

Study Record Dates

• First Submitted: June 6, 2026
• First Posted: June 15, 2026
• Study Start: August 4, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: June 15, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

YE (1)