RecruitingNot ApplicableNCT07648706

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

Sponsor

Sana'a University

Enrollment

268 participants

Start Date

Aug 4, 2024

Study Type

INTERVENTIONAL

Conditions

Preeclampsia

Summary

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

Sex: FEMALEMin Age: 18 YearsMax Age: 40 Years

Inclusion Criteria5

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 Criteria10

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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Interventions

DIETARY_SUPPLEMENTVitamin D3

Arm 1: Oral vitamin D3 supplementation administered during pregnancy. Participants will receive : 50,000 IU every two weeks according to their randomized group assignment.

DIETARY_SUPPLEMENTVitamin D3

Oral vitamin D3 supplementation administered during pregnancy. Participants will receive : 5,000 IU every week according to their randomized group assignment.