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NCT07648706Recruiting

Vitamin D3 Supplementation Regimens and Preeclampsia Risk

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

Source: ClinicalTrials.gov · Last updated 15 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
268 (estimated)
First submitted
6 Jun 2026
Start date
4 Aug 2024
Primary completion date
31 Aug 2026
Lead sponsor
Sana'a University
NCT number
NCT07648706

What you commit to

  • Study type: Interventional
  • Planned participants: 268
  • From 4 Aug 2024 to the primary completion date, 31 Aug 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Uncontrolled chronic hypertension
  • Severe chronic kidney disease
  • Pre-existing diabetes mellitus
  • Autoimmune or immunological disorders
  • Thyroid disease

Lab values

  • Use of medications that affect vitamin D or calcium metabolism

Other

  • Current use of vitamin D supplementation before enrollment
  • Known fetal congenital anomalies
  • Primary hyperparathyroidism
  • Inability or unwillingness to comply with the study protocol or follow-up schedule

Who the study is looking for

  • 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.

Age in the registry: 18 years to 40 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Faculty of Medicine and Health Sciences, Sana'a University
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SanaaYemenRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.