Vitamin D3 Supplementation Regimens and Preeclampsia Risk

Sana'a University268 enrolled

Overview

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.

Vitamin D deficiency during pregnancy has been associated with advers maternal and neonatal outcomes, including an increased risk of preeclampsia.However,the optimal dosage regimen of vitamin D3 supplementation in deficient pregnant women remains uncertain. This randomized controlled trial will be conducted at Al-Thawra Modern General Hospital in Sana'a, Yemen, and will include pregnant women with confirmed vitamin D deficiency in early pregnancy. Participants will be randomly assigned to one of two vitamin D3 supplementation regimens and followed throughout pregnancy. The study aims to compare the effectiveness of two different vitamin D3 dosing scheduales in reducing the incidence of preeclampsia.Maternal vitamin D status and pregnancy outcomes will be assessed as secondary measures to evaluate the overall impact of supplementation.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Incidence of Pre-eclampsia events

Occurance of preeclampsia during pregnancy , diagnosed according standared clinical criteria including new onset hypertention after 20weeks of gestation with proteinuria or other feature of maternal organ dysfunction.

Time frame: From 20 weeks of gestation until delivery

Secondary Outcomes

Severity of Preeclampsia

Description Severity of preeclampsia assessed by the need for preterm delivery, maternal intensive care unit admission, or other severe maternal complications.

Time frame: At diagnosis of preeclampsia until delivery

Gestational Age at Onset of Preeclampsia

Gestational age in weeks at the time of first diagnosis of preeclampsia.

Time frame: At first diagnosis of preeclampsia

Occurrence of Severe Maternal Complications

Occurrence of HELLP syndrome, eclampsia, or placental abruption during pregnancy

Time frame: From enrollment until delivery

Incidence of Gestational Diabetes Mellitus

Occurrence of gestational diabetes diagnosed according to standard clinical criteria.

Time frame: From enrollment until delivery]

Incidence of Gestational Hypertension

Occurrence of gestational hypertension diagnosed according to standard clinical criteria.

Time frame: From enrollment until delivery

Maternal Mortality

Death of a participant during pregnancy or within 42 days after termination of pregnancy.

Time frame: From enrollment until 42 days postpartum

Incidence of Low Birth Weight

Proportion of newborns with birth weight less than 2500 grams.

Time frame: At birth

Incidence of Preterm Birth

Delivery occurring before 37 completed weeks of gestation.

Time frame: At delivery

Neonatal Intensive Care Admission

Admission of the newborn to a neonatal intensive care unit.

Time frame: At birth

Mean Birth Weight

Birth weight of newborns measured in grams.

Time frame: At birth

Neonatal Mortality

Death of a live-born infant during the neonatal period.

Time frame: From birth to 28 days of life

Vitamin D3 Supplementation Regimens and Preeclampsia Risk

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts