PreeclampsiaVitD-PE-RCTNCT07648706
Vitamin D3 Supplementation Regimens and Preeclampsia Risk
A study testing Vitamin D3 in people with Preeclampsia, run by Sana'a University at 1 site in Yemen.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Preeclampsia
- What is being tested?
- Vitamin D3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 268 participants
- Where
- 1 siteYemen
- Study dates
- 4 Aug 2024to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Yemen1 site, 1 recruiting
- Recruiting
Faculty of Medicine and Health Sciences, Sana'a University
Sanaa, Maeen District
Amany Omer Taib, MBBS, +967775851225, a.taib@su.edu.ye
About this study
Official title: 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.
Read more
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.
Read the detailed description
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.
- Conditions
- Preeclampsia
- Being tested
- Vitamin D3
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Dietary supplement
Arm 1:
Oral vitamin D3 supplementation administered during pregnancy. Participants will receive : 50,000 IU every two weeks according to their randomized group assignment.
Vitamin D3Dietary supplement
Oral vitamin D3 supplementation administered during pregnancy. Participants will receive : 5,000 IU every week according to their randomized group assignment.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Vitamin D3 50,000 IU every 2 weeks | Experimental | 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. Receives: Dietary Supplement: Vitamin D3 |
| Arm 2 : Vitamin D3 5,000 IU every week | Experimental | 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. Receives: Dietary Supplement: Vitamin D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Pre-eclampsia events
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.
Measured: From 20 weeks of gestation until delivery
Secondary outcomes (11)
Severity of Preeclampsia
Description Severity of preeclampsia assessed by the need for preterm delivery, maternal intensive care unit admission, or other severe maternal complications.
Measured: At diagnosis of preeclampsia until delivery
Gestational Age at Onset of Preeclampsia
Gestational age in weeks at the time of first diagnosis of preeclampsia.
Measured: At first diagnosis of preeclampsia
Occurrence of Severe Maternal Complications
Occurrence of HELLP syndrome, eclampsia, or placental abruption during pregnancy
Measured: From enrollment until delivery
Incidence of Gestational Diabetes Mellitus
Occurrence of gestational diabetes diagnosed according to standard clinical criteria.
Measured: From enrollment until delivery]
Incidence of Gestational Hypertension
Occurrence of gestational hypertension diagnosed according to standard clinical criteria.
Measured: From enrollment until delivery
Maternal Mortality
Death of a participant during pregnancy or within 42 days after termination of pregnancy.
Measured: From enrollment until 42 days postpartum
Incidence of Low Birth Weight
Proportion of newborns with birth weight less than 2500 grams.
Measured: At birth
Incidence of Preterm Birth
Delivery occurring before 37 completed weeks of gestation.
Measured: At delivery
Neonatal Intensive Care Admission
Admission of the newborn to a neonatal intensive care unit.
Measured: At birth
Mean Birth Weight
Birth weight of newborns measured in grams.
Measured: At birth
Neonatal Mortality
Death of a live-born infant during the neonatal period.
Measured: From birth to 28 days of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start4 Aug 2024
- Primary completionAug 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in a 1:1 ratio to one of two parallel intervention arms .Each arm will recive a different vitamin D3 supplementation regimen during pregnancy .Participants will remain in their assigned group throughout the study period until completion of follow-up Arm 1: Name: Vitamin D3 50,000 IU every 2 weeks Type: Experimental Intervention: Vitamin D3 Arm 2: Name: Vitamin D3 5,000 IU weekly Type: Experimental Intervention: Vitamin D3
- Masking
- None (open label)
- Enrolment
- 268 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sana'a University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amany Omer Yousef Taib, Sana'a University
- Investigators
- Amany Omer Taib, MBBS, Principal investigator, Faculty of Medicine and Health Sciences, Sana'a University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07648706
- Sponsor's protocol ID
- VitD-PE-2024
- Other IDs
- (26)-12-8
- Acronym
- VitD-PE-RCT
- Status last verified
- Jun 2026
- First submitted
- 6 Jun 2026
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Dosages of Vitamin D3 Supplementation on the Risk of Preeclampsia in Pregnant Women With Vitamin D Deficiency
- ClinicalTrials.gov ID
- NCT07648706
- Acronym / sponsor ID
- VitD-PE-RCT / VitD-PE-2024
- Conditions
- Preeclampsia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 268 participants (estimated)
- Lead sponsor
- Sana'a UniversityUniversity, hospital or other
- Study start
- 4 Aug 2024 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 15 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to one of two parallel intervention arms .Each arm will recive a different vitamin D3 supplementation regimen during pregnancy .Participants will remain in their assigned group throughout the study period until completion of follow-up Arm 1: Name: Vitamin D3 50,000 IU every 2 weeks Type: Experimental Intervention: Vitamin D3 Arm 2: Name: Vitamin D3 5,000 IU weekly Type: Experimental Intervention: Vitamin D3
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Vitamin D3 50,000 IU every 2 weeks | Experimental | Dietary Supplement: Vitamin D3Participants 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. |
| Arm 2 : Vitamin D3 5,000 IU every week | Experimental | Dietary Supplement: Vitamin D3Participants 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- Uncontrolled chronic hypertension
- Current use of vitamin D supplementation before enrollment
- Severe chronic kidney disease
- Pre-existing diabetes mellitus
- Autoimmune or immunological disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D3Arm 1: Oral vitamin D3 supplementation administered during pregnancy. Participants will receive : 50,000 IU every two weeks according to their randomized group assignment. | Dietary supplement | Arm 1: Vitamin D3 50,000 IU every 2 weeks |
| Vitamin D3Oral vitamin D3 supplementation administered during pregnancy. Participants will receive : 5,000 IU every week according to their randomized group assignment. | Dietary supplement | Arm 2 : Vitamin D3 5,000 IU every week |
Primary outcome
Incidence of Pre-eclampsia events
Time frame: 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.
11 secondary outcomes
Severity of Preeclampsia
Time frame: At diagnosis of preeclampsia until delivery
Gestational Age at Onset of Preeclampsia
Time frame: At first diagnosis of preeclampsia
Occurrence of Severe Maternal Complications
Time frame: From enrollment until delivery
Incidence of Gestational Diabetes Mellitus
Time frame: From enrollment until delivery]
Incidence of Gestational Hypertension
Time frame: From enrollment until delivery
Maternal Mortality
Time frame: From enrollment until 42 days postpartum
Incidence of Low Birth Weight
Time frame: At birth
Incidence of Preterm Birth
Time frame: At delivery
Neonatal Intensive Care Admission
Time frame: At birth
Mean Birth Weight
Time frame: At birth
Neonatal Mortality
Time frame: From birth to 28 days of life
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Individual participant dataSharing planned: No. 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.
Related trials for Preeclampsia
Recruiting
Exercise to Improve Heart and Metabolic Health After Childbirth in Women at High Risk for Preeclampsia
Postpartum Exercise, Cardiometabolic Health
RecruitingObservational study
Molecular Study of the Maternal-fetal Interface in Preeclampsia.
Preeclampsia
Active, not recruitingObservational study
The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
Pre-Eclampsia, Atherosclerosis
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Not yet recruitingPhase 2
Furosemide vs Placebo in Severe Preeclampsia Postpartum
Severe Preeclampsia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amany Omer Taib, MBBS principal investigator
Faculty of Medicine and Health Sciences, Sana'a University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D3 in people with Preeclampsia, run by Sana'a University at 1 site in Yemen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Yemen. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amany Omer Taib, MBBS (+967775851225, a.taib@su.edu.ye), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Pre-eclampsia events (time frame: From 20 weeks of gestation until delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.