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NCT Number: NCT07648706

Vitamin D3 Supplementation Regimens and Preeclampsia Risk

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.

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Key information

Conditions

Preeclampsia Female Urogenital Diseases and Pregnancy Complications Hypertension, Pregnancy-Induced Pre-Eclampsia Pregnancy Complications Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine and Health Sciences, Sana'a University

Sanaa, Maeen District, Yemen

Location status: Recruiting

Location contact

Amany Omer Taib, MBBS

CONTACT

[email protected]

+967775851225

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Incidence of Pre-eclampsia events

    Time frame: From 20 weeks of gestation until delivery

    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.

Secondary outcomes

  1. Severity of Preeclampsia

    Time frame: At diagnosis of preeclampsia until delivery

    Description Severity of preeclampsia assessed by the need for preterm delivery, maternal intensive care unit admission, or other severe maternal complications.

  2. Gestational Age at Onset of Preeclampsia

    Time frame: At first diagnosis of preeclampsia

    Gestational age in weeks at the time of first diagnosis of preeclampsia.

  3. Occurrence of Severe Maternal Complications

    Time frame: From enrollment until delivery

    Occurrence of HELLP syndrome, eclampsia, or placental abruption during pregnancy

  4. Incidence of Gestational Diabetes Mellitus

    Time frame: From enrollment until delivery]

    Occurrence of gestational diabetes diagnosed according to standard clinical criteria.

  5. Incidence of Gestational Hypertension

    Time frame: From enrollment until delivery

    Occurrence of gestational hypertension diagnosed according to standard clinical criteria.

  6. Maternal Mortality

    Time frame: From enrollment until 42 days postpartum

    Death of a participant during pregnancy or within 42 days after termination of pregnancy.

  7. Incidence of Low Birth Weight

    Time frame: At birth

    Proportion of newborns with birth weight less than 2500 grams.

  8. Incidence of Preterm Birth

    Time frame: At delivery

    Delivery occurring before 37 completed weeks of gestation.

  9. Neonatal Intensive Care Admission

    Time frame: At birth

    Admission of the newborn to a neonatal intensive care unit.

  10. Mean Birth Weight

    Time frame: At birth

    Birth weight of newborns measured in grams.

  11. Neonatal Mortality

    Time frame: From birth to 28 days of life

    Death of a live-born infant during the neonatal period.

Study contacts

Contact information is provided by the study sponsor or research team.

Amany Omer Taib, MBBS

CONTACT

[email protected]

+967775851225

Sponsors and collaborators

Lead sponsor

Sana'a University

Other

Registry information

Official study title

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

Acronym: VitD-PE-RCT

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 15, 2026
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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