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

12 juni 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

268

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: Amany Omer Taib, MBBS
  • Telefoonnummer: +967775851225
  • E-mail: a.taib@su.edu.ye

Studie Locaties

  • Jemen
    • Maeen District
      • Sanaa, Maeen District, Jemen
        • Werving
        • Faculty of Medicine and Health Sciences, Sana'a University
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Voedingssupplement: 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.

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

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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Incidence of Pre-eclampsia events
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Severity of Preeclampsia
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: From enrollment until delivery
Occurrence of HELLP syndrome, eclampsia, or placental abruption during pregnancy
From enrollment until delivery
Incidence of Gestational Diabetes Mellitus
Tijdsspanne: From enrollment until delivery]
Occurrence of gestational diabetes diagnosed according to standard clinical criteria.
From enrollment until delivery]
Incidence of Gestational Hypertension
Tijdsspanne: From enrollment until delivery
Occurrence of gestational hypertension diagnosed according to standard clinical criteria.
From enrollment until delivery
Maternal Mortality
Tijdsspanne: 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
Tijdsspanne: At birth
Proportion of newborns with birth weight less than 2500 grams.
At birth
Incidence of Preterm Birth
Tijdsspanne: At delivery
Delivery occurring before 37 completed weeks of gestation.
At delivery
Neonatal Intensive Care Admission
Tijdsspanne: At birth
Admission of the newborn to a neonatal intensive care unit.
At birth
Mean Birth Weight
Tijdsspanne: At birth
Birth weight of newborns measured in grams.
At birth
Neonatal Mortality
Tijdsspanne: From birth to 28 days of life
Death of a live-born infant during the neonatal period.
From birth to 28 days of life

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Sana'a University

Onderzoekers

  • Hoofdonderzoeker: Amany Omer Taib, MBBS, Faculty of Medicine and Health Sciences, Sana'a University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

4 augustus 2024

Primaire voltooiing (Geschat)

1 augustus 2026

Studie voltooiing (Geschat)

1 september 2026

Studieregistratiedata

Eerst ingediend

6 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

12 juni 2026

Eerst geplaatst (Werkelijk)

15 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

15 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

12 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • VitD-PE-2024
  • (26)-12-8 (Andere identificatie: Research Ethics Committee-Sana'a University)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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