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