An interventional study of Vitamin D3 and Vitamin D3 in Preeclampsia, sponsored by Sana'a University. Recruiting at 1 site in Yemen. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-06-15.
Sponsored by Sana'a University · Not applicable, Interventional, and Prevention
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.
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.
916 studies on the registry are indexed under Pre-Eclampsia; 243 are open to participants now.
This study's planned enrollment of 268 is above the median of 110 across 480 interventional studies indexed under Pre-Eclampsia.
Browse Pre-Eclampsia studies →Sana'a University is the lead sponsor of 27 studies on the registry; 15 are open to participants now.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Dietary Supplement: Vitamin D3
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.
Dietary Supplement: 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.
Oral vitamin D3 supplementation administered during pregnancy. Participants will receive : 5,000 IU every week according to their randomized group assignment.
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.
Time frame: From 20 weeks of gestation until delivery
Severity of Preeclampsia
Description Severity of preeclampsia assessed by the need for preterm delivery, maternal intensive care unit admission, or other severe maternal complications.
Time frame: At diagnosis of preeclampsia until delivery
Gestational Age at Onset of Preeclampsia
Gestational age in weeks at the time of first diagnosis of preeclampsia.
Time frame: At first diagnosis of preeclampsia
Occurrence of Severe Maternal Complications
Occurrence of HELLP syndrome, eclampsia, or placental abruption during pregnancy
Time frame: From enrollment until delivery
Incidence of Gestational Diabetes Mellitus
Occurrence of gestational diabetes diagnosed according to standard clinical criteria.
Time frame: From enrollment until delivery]
Incidence of Gestational Hypertension
Occurrence of gestational hypertension diagnosed according to standard clinical criteria.
Time frame: From enrollment until delivery
Maternal Mortality
Death of a participant during pregnancy or within 42 days after termination of pregnancy.
Time frame: From enrollment until 42 days postpartum
Incidence of Low Birth Weight
Proportion of newborns with birth weight less than 2500 grams.
Time frame: At birth
Incidence of Preterm Birth
Delivery occurring before 37 completed weeks of gestation.
Time frame: At delivery
Neonatal Intensive Care Admission
Admission of the newborn to a neonatal intensive care unit.
Time frame: At birth
Mean Birth Weight
Birth weight of newborns measured in grams.
Time frame: At birth
Neonatal Mortality
Death of a live-born infant during the neonatal period.
Time frame: From birth to 28 days of life
Plan to share: 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.
No publications or documents are linked to this record.
Started Aug 2024 (actual). Primary completion is estimated for Aug 2026, 24 months after the start.
Of 171 non-industry interventional studies with no phase under Pre-Eclampsia, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 43. This study's planned 24 months is close to that.
Counting every sponsor, half of 176 studies reached it within 24 months; a quarter within 9 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
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Sana'a University