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| ID | Type | Description | Link |
|---|---|---|---|
| (26)-12-8 | Other Identifier | Research Ethics Committee-Sana'a University |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D3 | Dietary 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From 20 weeks of gestation until delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of Preeclampsia | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amany Omer Taib, MBBS | Contact | +967775851225 | a.taib@su.edu.ye |
| Name | Affiliation | Role |
|---|---|---|
| Amany Omer Taib, MBBS | Faculty of Medicine and Health Sciences, Sana'a University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine and Health Sciences, Sana'a University | Recruiting | Sanaa | Maeen District | Yemen |
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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| ID | Term |
|---|---|
| D011225 | Pre-Eclampsia |
| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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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
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No additional masking beyond those specified.
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| Vitamin D3 | Dietary Supplement | Oral vitamin D3 supplementation administered during pregnancy. Participants will receive : 5,000 IU every week according to their randomized group assignment. |
|
Gestational age in weeks at the time of first diagnosis of preeclampsia. |
| At first diagnosis of preeclampsia |
| Occurrence of Severe Maternal Complications | Occurrence of HELLP syndrome, eclampsia, or placental abruption during pregnancy | From enrollment until delivery |
| Incidence of Gestational Diabetes Mellitus | Occurrence of gestational diabetes diagnosed according to standard clinical criteria. | From enrollment until delivery] |
| Incidence of Gestational Hypertension | Occurrence of gestational hypertension diagnosed according to standard clinical criteria. | From enrollment until delivery |
| Maternal Mortality | 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 | Proportion of newborns with birth weight less than 2500 grams. | At birth |
| Incidence of Preterm Birth | Delivery occurring before 37 completed weeks of gestation. | At delivery |
| Neonatal Intensive Care Admission | Admission of the newborn to a neonatal intensive care unit. | At birth |
| Mean Birth Weight | Birth weight of newborns measured in grams. | At birth |
| Neonatal Mortality | Death of a live-born infant during the neonatal period. | From birth to 28 days of life |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |