Vitamin D3 Supplementation Regimens and Preeclampsia Risk

ConditionPreeclampsia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorSana'a University

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Uncontrolled chronic hypertension

Current use of vitamin D supplementation before enrollment

Severe chronic kidney disease

Pre-existing diabetes mellitus

Trial design

Treatments tested in this trial

  • Vitamin D3
  • Vitamin D3

Treatment groups

268 Participants
are divided into 2 treatment groups

Sponsors and collaborators