Vitamin D3 Supplementation Regimens and Preeclampsia Risk

Официальное название

Effect of Different Dosages of Vitamin D3 Supplementation on the Risk of Preeclampsia in Pregnant Women With Vitamin D Deficiency

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Incidence of Pre-eclampsia events [Срок оценки: From 20 weeks of gestation until delivery]

Вторичные конечные точки (11)

• Severity of Preeclampsia [Срок оценки: At diagnosis of preeclampsia until delivery]
• Gestational Age at Onset of Preeclampsia [Срок оценки: At first diagnosis of preeclampsia]
• Occurrence of Severe Maternal Complications [Срок оценки: From enrollment until delivery]
• Incidence of Gestational Diabetes Mellitus [Срок оценки: From enrollment until delivery]]
• Incidence of Gestational Hypertension [Срок оценки: From enrollment until delivery]
• Maternal Mortality [Срок оценки: From enrollment until 42 days postpartum]
• Incidence of Low Birth Weight [Срок оценки: At birth]
• Incidence of Preterm Birth [Срок оценки: At delivery]
• Neonatal Intensive Care Admission [Срок оценки: At birth]
• Mean Birth Weight [Срок оценки: At birth]
• Neonatal Mortality [Срок оценки: From birth to 28 days of life]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Yemen · 1 центр

• Faculty of Medicine and Health Sciences, Sana'a University — Sanaa

Идентификаторы

NCT: NCT07648706 · VitD-PE-2024 · (26)-12-8

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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