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Recruiting NCT07648706

Vitamin D3 Supplementation Regimens and Preeclampsia Risk

No phase Interventional Preeclampsia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Vitamin D3, Vitamin D3.
Who it may be relevant to
Registry conditions: Preeclampsia. Basic parameters: 18 years — 40 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Yemen
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

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.

Detailed description

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.

Interventions

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

Primary outcome measures

  • Incidence of Pre-eclampsia events [Time frame: From 20 weeks of gestation until delivery]
Secondary outcome measures (11)
  • Severity of Preeclampsia [Time frame: At diagnosis of preeclampsia until delivery]
  • Gestational Age at Onset of Preeclampsia [Time frame: At first diagnosis of preeclampsia]
  • Occurrence of Severe Maternal Complications [Time frame: From enrollment until delivery]
  • Incidence of Gestational Diabetes Mellitus [Time frame: From enrollment until delivery]]
  • Incidence of Gestational Hypertension [Time frame: From enrollment until delivery]
  • Maternal Mortality [Time frame: From enrollment until 42 days postpartum]
  • Incidence of Low Birth Weight [Time frame: At birth]
  • Incidence of Preterm Birth [Time frame: At delivery]
  • Neonatal Intensive Care Admission [Time frame: At birth]
  • Mean Birth Weight [Time frame: At birth]
  • Neonatal Mortality [Time frame: From birth to 28 days of life]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Yemen · 1 center
  • Faculty of Medicine and Health Sciences, Sana'a University — Sanaa

Identifiers

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

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗