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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…

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ClinicalTrials.gov IDNCT07648706
PhaseNA
Enrollment268
SponsorSana'a University
Age18 Years – 40 Years
SexFEMALE
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Conditions studied

Preeclampsia

About this study

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.

Interventions

Primary outcomes

Eligibility information

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 locations

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-11-12.