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

12. juni 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Intervensjonell

Registrering (Antatt)

268

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

  • Navn: Amany Omer Taib, MBBS
  • Telefonnummer: +967775851225
  • E-post: a.taib@su.edu.ye

Studiesteder

  • Jemen
    • Maeen District
      • Sanaa, Maeen District, Jemen
        • Rekruttering
        • Faculty of Medicine and Health Sciences, Sana'a University
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Kosttilskudd: 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.

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

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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Incidence of Pre-eclampsia events
Tidsramme: 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

Sekundære resultatmål

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Sana'a University

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

4. august 2024

Primær fullføring (Antatt)

1. august 2026

Studiet fullført (Antatt)

1. september 2026

Datoer for studieregistrering

Først innsendt

6. juni 2026

Først innsendt som oppfylte QC-kriteriene

12. juni 2026

Først lagt ut (Faktiske)

15. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

15. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

12. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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