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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Amany Omer Taib, MBBS
- Numéro de téléphone: +967775851225
- E-mail: a.taib@su.edu.ye
Lieux d'étude
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Maeen District
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Sanaa, Maeen District, Yémen
- Recrutement
- Faculty of Medicine and Health Sciences, Sana'a University
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Contact:
- Amany Omer Taib, MBBS
- Numéro de téléphone: +967775851225
- E-mail: a.taib@su.edu.ye
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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|
Expérimental: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Incidence of Pre-eclampsia events
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Severity of Preeclampsia
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Amany Omer Taib, MBBS, Faculty of Medicine and Health Sciences, Sana'a University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies urogénitales
- Maladies urogénitales féminines et complications de la grossesse
- Complications de grossesse
- Hypertension induite par la grossesse
- Pré-éclampsie
- Lipides
- Composés polycycliques
- Stéroïdes
- Composés à anneau fusionné
- Cholesténènes
- Cholestanes
- Stérols
- Vitamine D
- Secostéroïdes
- Lipides membranaires
- Cholécalciférol
Autres numéros d'identification d'étude
- VitD-PE-2024
- (26)-12-8 (Autre identifiant: Research Ethics Committee-Sana'a University)
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
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