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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Amany Omer Taib, MBBS
- Número de telefone: +967775851225
- E-mail: a.taib@su.edu.ye
Locais de estudo
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Maeen District
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Sanaa, Maeen District, Iémen
- Recrutamento
- Faculty of Medicine and Health Sciences, Sana'a University
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Contato:
- Amany Omer Taib, MBBS
- Número de telefone: +967775851225
- E-mail: a.taib@su.edu.ye
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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.
|
|
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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Incidence of Pre-eclampsia events
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Severity of Preeclampsia
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Doenças urogenitais
- Doenças urogenitais femininas e complicações na gravidez
- Complicações na Gravidez
- Hipertensão Induzida pela Gravidez
- Pré-eclâmpsia
- Lipídios
- Compostos policíclicos
- Esteróides
- Compostos de anel fundido
- CHOLESTENES
- Colestanos
- Esteróis
- Vitamina d
- Secosteróides
- Lipídios da membrana
- Colecalciferol
Outros números de identificação do estudo
- VitD-PE-2024
- (26)-12-8 (Outro identificador: Research Ethics Committee-Sana'a University)
Plano para dados de participantes individuais (IPD)
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Descrição do plano IPD
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