Vitamin D3 Regimens to See If They Lower Preeclampsia Risk

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized controlled trial compares two vitamin D3 dosing regimens in pregnant women with confirmed vitamin D deficiency. Participants with singleton pregnancies between 8 and 18 weeks gestation and low 25(OH)D levels are assigned to either 50,000 IU of vitamin D3 every two weeks or 5,000 IU weekly, in addition to standard prenatal care. The primary outcome is the incidence of preeclampsia, with maternal vitamin D status and pregnancy outcomes as secondary measures. The study is conducted at Al-Thawra Modern General Hospital in Sana'a, Yemen, led by Sana'a University, with careful exclusion of conditions that could confound results. The goal is to determine if dosing strategy influences preeclampsia risk in deficient pregnant women.

Why it matters

Who can join: the full rules

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

Where it's running

• Faculty of Medicine and Health Sciences, Sana'a University
  Sanaa, Maeen District, Yemen Recruiting

Study contacts

• Principal investigator: Amany Omer Taib, MBBS — Faculty of Medicine and Health Sciences, Sana'a University
• Study coordinator: Amany Omer Taib, MBBS
• Email: a.taib@su.edu.ye
• Phone: +967775851225

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.