Vitamin D3 Supplementation Regimens and Preeclampsia Risk (VitD-PE-RCT)
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Amany Omer Taib, MBBS
- Número de teléfono: +967775851225
- Correo electrónico: a.taib@su.edu.ye
Ubicaciones de estudio
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Maeen District
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Sanaa, Maeen District, Yemen
- Reclutamiento
- Faculty of Medicine and Health Sciences, Sana'a University
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Contacto:
- Amany Omer Taib, MBBS
- Número de teléfono: +967775851225
- Correo electrónico: a.taib@su.edu.ye
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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.
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Arm 1: Oral vitamin D3 supplementation administered during pregnancy. Participants will receive : 50,000 IU every two weeks according to their randomized group assignment.
Oral vitamin D3 supplementation administered during pregnancy.
Participants will receive : 5,000 IU every week according to their randomized group assignment.
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Experimental: 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.
|
Arm 1: Oral vitamin D3 supplementation administered during pregnancy. Participants will receive : 50,000 IU every two weeks according to their randomized group assignment.
Oral vitamin D3 supplementation administered during pregnancy.
Participants will receive : 5,000 IU every week according to their randomized group assignment.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Incidence of Pre-eclampsia events
Periodo de tiempo: From 20 weeks of gestation until delivery
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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.
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From 20 weeks of gestation until delivery
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Severity of Preeclampsia
Periodo de tiempo: At diagnosis of preeclampsia until delivery
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Description Severity of preeclampsia assessed by the need for preterm delivery, maternal intensive care unit admission, or other severe maternal complications.
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At diagnosis of preeclampsia until delivery
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Gestational Age at Onset of Preeclampsia
Periodo de tiempo: At first diagnosis of preeclampsia
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Gestational age in weeks at the time of first diagnosis of preeclampsia.
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At first diagnosis of preeclampsia
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Occurrence of Severe Maternal Complications
Periodo de tiempo: From enrollment until delivery
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Occurrence of HELLP syndrome, eclampsia, or placental abruption during pregnancy
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From enrollment until delivery
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Incidence of Gestational Diabetes Mellitus
Periodo de tiempo: From enrollment until delivery]
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Occurrence of gestational diabetes diagnosed according to standard clinical criteria.
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From enrollment until delivery]
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Incidence of Gestational Hypertension
Periodo de tiempo: From enrollment until delivery
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Occurrence of gestational hypertension diagnosed according to standard clinical criteria.
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From enrollment until delivery
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Maternal Mortality
Periodo de tiempo: From enrollment until 42 days postpartum
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Death of a participant during pregnancy or within 42 days after termination of pregnancy.
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From enrollment until 42 days postpartum
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Incidence of Low Birth Weight
Periodo de tiempo: At birth
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Proportion of newborns with birth weight less than 2500 grams.
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At birth
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Incidence of Preterm Birth
Periodo de tiempo: At delivery
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Delivery occurring before 37 completed weeks of gestation.
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At delivery
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Neonatal Intensive Care Admission
Periodo de tiempo: At birth
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Admission of the newborn to a neonatal intensive care unit.
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At birth
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Mean Birth Weight
Periodo de tiempo: At birth
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Birth weight of newborns measured in grams.
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At birth
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Neonatal Mortality
Periodo de tiempo: From birth to 28 days of life
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Death of a live-born infant during the neonatal period.
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From birth to 28 days of life
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Amany Omer Taib, MBBS, Faculty of Medicine and Health Sciences, Sana'a University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Complicaciones del embarazo
- Hipertensión, inducida por el embarazo
- Preeclampsia
- Lípidos
- Compuestos policíclicos
- Esteroides
- Compuestos de anillo fusionado
- Cholestenes
- Colestanos
- Esteroles
- Vitamina D
- Subesteroides
- Lípidos de membrana
- Colecalciferol
Otros números de identificación del estudio
- VitD-PE-2024
- (26)-12-8 (Otro identificador: Research Ethics Committee-Sana'a University)
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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