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

12 juni 2026 uppdaterad 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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

268

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

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

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Kosttillskott: 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.

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

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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Incidence of Pre-eclampsia events
Tidsram: 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

Sekundära resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Sana'a University

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

4 augusti 2024

Primärt slutförande (Beräknad)

1 augusti 2026

Avslutad studie (Beräknad)

1 september 2026

Studieregistreringsdatum

Först inskickad

6 juni 2026

Först inskickad som uppfyllde QC-kriterierna

12 juni 2026

Första postat (Faktisk)

15 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

15 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

12 juni 2026

Senast verifierad

1 juni 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

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

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

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.

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