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Vitamin D3 Supplementation Regimens and Preeclampsia Risk (VitD-PE-RCT)

2026年6月12日 更新者：Amany Omer Yousef Taib、Sana'a University

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

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.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

268

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名：Amany Omer Taib, MBBS
  • 电话号码：+967775851225
  • 邮箱：a.taib@su.edu.ye

学习地点

  • 也门
    • Maeen District
      • Sanaa、Maeen District、也门
        • 招聘中
        • Faculty of Medicine and Health Sciences, Sana'a University
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

不

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：预防
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Arm 1: Vitamin D3 50,000 IU every 2 weeks
Participants in this arm will receive oral vitamin D3 supplementation at a dose of 50,000 IU every 2 weekly in addition to routine antenatal care. Supplementation will continue from enrollment until delivery, and participants will be monitored throughout pregnancy for the development of preeclampsia and other maternal and neonatal outcomes.
膳食补充剂：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.

膳食补充剂：Vitamin D3
Oral vitamin D3 supplementation administered during pregnancy. Participants will receive : 5,000 IU every week according to their randomized group assignment.
实验性的：Arm 2 : Vitamin D3 5,000 IU every week
Participants in this arm will receive oral vitamin D3 supplementation at a dose of 5,000 IU once weekly in addition to routine antenatal care. Supplementation will continue from enrollment until delivery, and participants will be monitored throughout pregnancy for the development of preeclampsia and other maternal and neonatal outcomes.
膳食补充剂：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.

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

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Incidence of Pre-eclampsia events
大体时间：From 20 weeks of gestation until delivery
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.
From 20 weeks of gestation until delivery

次要结果测量

结果测量
措施说明
大体时间
Severity of Preeclampsia
大体时间：At diagnosis of preeclampsia until delivery
Description Severity of preeclampsia assessed by the need for preterm delivery, maternal intensive care unit admission, or other severe maternal complications.
At diagnosis of preeclampsia until delivery
Gestational Age at Onset of Preeclampsia
大体时间：At first diagnosis of preeclampsia
Gestational age in weeks at the time of first diagnosis of preeclampsia.
At first diagnosis of preeclampsia
Occurrence of Severe Maternal Complications
大体时间：From enrollment until delivery
Occurrence of HELLP syndrome, eclampsia, or placental abruption during pregnancy
From enrollment until delivery
Incidence of Gestational Diabetes Mellitus
大体时间：From enrollment until delivery]
Occurrence of gestational diabetes diagnosed according to standard clinical criteria.
From enrollment until delivery]
Incidence of Gestational Hypertension
大体时间：From enrollment until delivery
Occurrence of gestational hypertension diagnosed according to standard clinical criteria.
From enrollment until delivery
Maternal Mortality
大体时间：From enrollment until 42 days postpartum
Death of a participant during pregnancy or within 42 days after termination of pregnancy.
From enrollment until 42 days postpartum
Incidence of Low Birth Weight
大体时间：At birth
Proportion of newborns with birth weight less than 2500 grams.
At birth
Incidence of Preterm Birth
大体时间：At delivery
Delivery occurring before 37 completed weeks of gestation.
At delivery
Neonatal Intensive Care Admission
大体时间：At birth
Admission of the newborn to a neonatal intensive care unit.
At birth
Mean Birth Weight
大体时间：At birth
Birth weight of newborns measured in grams.
At birth
Neonatal Mortality
大体时间：From birth to 28 days of life
Death of a live-born infant during the neonatal period.
From birth to 28 days of life

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Sana'a University

调查人员

  • 首席研究员：Amany Omer Taib, MBBS、Faculty of Medicine and Health Sciences, Sana'a University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年8月4日

初级完成 (估计的)

2026年8月1日

研究完成 (估计的)

2026年9月1日

研究注册日期

首次提交

2026年6月6日

首先提交符合 QC 标准的

2026年6月12日

首次发布 (实际的)

2026年6月15日

研究记录更新

最后更新发布 (实际的)

2026年6月15日

上次提交的符合 QC 标准的更新

2026年6月12日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • VitD-PE-2024
  • (26)-12-8 (其他标识符：Research Ethics Committee-Sana'a University)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

Individual participant data(IPD) will not be made publicly available. Data will be used solely for the purposes of this study and related scientific publications.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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