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Vitamin D3 Supplementation Regimens and Preeclampsia Risk

RecruitingNAAges 18 Years - 40 YearsFemaleSana'a University
NCT07648706 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 exclu

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📋 Eligibility rules (as published)
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
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What it tests

  • Vitamin D3
  • Vitamin D3
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Where

1 site
Faculty of Medicine and Health Sciences, Sana'a University
Sanaa, Yemen
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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