[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100642709":3},{"organization":4,"outcomesModule":7,"designInfo":56,"detailedDescription":64,"studyPopulation":55,"armGroups":65,"interventions":76,"overallOfficials":85,"centralContacts":90,"locations":95,"responsibleParty":110,"collaborators":55,"id":113,"slug":114,"hasResults":115,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":119,"eligibilityCriteria":120,"healthyVolunteers":115,"sex":121,"minAge":122,"maxAge":123,"enrollmentInfo":124,"targetDuration":55,"studyType":127,"phases":128,"briefSummary":130,"conditions":131,"keywords":55,"overallStatus":97,"whyStopped":55,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":142},{"fullName":5,"class":6},"Sana'a University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":55},[9],{"measure":10,"description":11,"timeFrame":12},"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",[14,18,22,26,30,33,37,41,45,48,51],{"measure":15,"description":16,"timeFrame":17},"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",{"measure":19,"description":20,"timeFrame":21},"Gestational Age at Onset of Preeclampsia","Gestational age in weeks at the time of first diagnosis of preeclampsia.","At first diagnosis of preeclampsia",{"measure":23,"description":24,"timeFrame":25},"Occurrence of Severe Maternal Complications","Occurrence of HELLP syndrome, eclampsia, or placental abruption during pregnancy","From enrollment until delivery",{"measure":27,"description":28,"timeFrame":29},"Incidence of Gestational Diabetes Mellitus","Occurrence of gestational diabetes diagnosed according to standard clinical criteria.","From enrollment until delivery]",{"measure":31,"description":32,"timeFrame":25},"Incidence of Gestational Hypertension","Occurrence of gestational hypertension diagnosed according to standard clinical criteria.",{"measure":34,"description":35,"timeFrame":36},"Maternal Mortality","Death of a participant during pregnancy or within 42 days after termination of pregnancy.","From enrollment until 42 days postpartum",{"measure":38,"description":39,"timeFrame":40},"Incidence of Low Birth Weight","Proportion of newborns with birth weight less than 2500 grams.","At birth",{"measure":42,"description":43,"timeFrame":44},"Incidence of Preterm Birth","Delivery occurring before 37 completed weeks of gestation.","At delivery",{"measure":46,"description":47,"timeFrame":40},"Neonatal Intensive Care Admission","Admission of the newborn to a neonatal intensive care unit.",{"measure":49,"description":50,"timeFrame":40},"Mean Birth Weight","Birth weight of newborns measured in grams.",{"measure":52,"description":53,"timeFrame":54},"Neonatal Mortality","Death of a live-born infant during the neonatal period.","From birth to 28 days of life",null,{"allocation":57,"interventionModel":58,"interventionModelDescription":59,"primaryPurpose":60,"observationalModel":55,"timePerspective":55,"maskingInfo":61},"RANDOMIZED","PARALLEL","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\n\nArm 1:\n\nName: Vitamin D3 50,000 IU every 2 weeks Type: Experimental Intervention: Vitamin D3\n\nArm 2:\n\nName: Vitamin D3 5,000 IU weekly Type: Experimental Intervention: Vitamin D3","PREVENTION",{"masking":62,"maskingDescription":63,"whoMasked":55},"NONE","No additional masking beyond those specified.","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.\n\nThis 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.\n\nThe 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.",[66,72],{"label":67,"type":68,"description":69,"interventionNames":70},"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.",[71],"Dietary Supplement: Vitamin D3",{"label":73,"type":68,"description":74,"interventionNames":75},"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.",[71],[77,82],{"type":78,"name":79,"description":80,"armGroupLabels":81,"otherNames":55},"DIETARY_SUPPLEMENT","Vitamin D3","Arm 1:\n\nOral vitamin D3 supplementation administered during pregnancy. Participants will receive : 50,000 IU every two weeks according to their randomized group assignment.",[67],{"type":78,"name":79,"description":83,"armGroupLabels":84,"otherNames":55},"Oral vitamin D3 supplementation administered during pregnancy. Participants will receive : 5,000 IU every week according to their randomized group assignment.",[73],[86],{"name":87,"affiliation":88,"role":89},"Amany Omer Taib, MBBS","Faculty of Medicine and Health Sciences, Sana'a University","PRINCIPAL_INVESTIGATOR",[91],{"name":87,"role":92,"phone":93,"phoneExt":55,"email":94},"CONTACT","+967775851225","a.taib@su.edu.ye",[96],{"facility":88,"status":97,"city":98,"state":99,"zip":55,"country":100,"countryCode":101,"cosmosGeoPoint":102,"geoPoint":107,"contacts":108},"RECRUITING","Sanaa","Maeen District","Yemen","YE",{"type":103,"coordinates":104},"Point",[105,106],44.20646,15.35452,{"lat":106,"lon":105},[109],{"name":87,"role":92,"phone":93,"phoneExt":55,"email":94},{"type":89,"investigatorFullName":111,"investigatorTitle":112,"investigatorAffiliation":5,"oldNameTitle":55,"oldOrganization":55},"Amany Omer Yousef Taib","Resident Doctor - Obstetrics & Gynecology","100642709","vitamin-d3-supplementation-regimens-and-preeclampsia-risk-100642709",false,"NCT07648706","Vitamin D3 Supplementation Regimens and Preeclampsia Risk","Effect of Different Dosages of Vitamin D3 Supplementation on the Risk of Preeclampsia in Pregnant Women With Vitamin D Deficiency","VitD-PE-RCT","Inclusion Criteria:\n\n* Singleton pregnancy\n* Pregnant women between 8 and 18 weeks of gestation\n* Serum 25-hydroxyvitamin D \\[25(OH)D\\] level \\\u003C 25 ng\u002FmL\n* Willing and able to provide written informed consent\n* Planning to receive ongoing antenatal care and deliver at Al-Thawra Modern General Hospital.\n\nExclusion Criteria:\n\n* Uncontrolled chronic hypertension\n* Current use of vitamin D supplementation before enrollment\n* Severe chronic kidney disease\n* Pre-existing diabetes mellitus\n* Autoimmune or immunological disorders\n* Known fetal congenital anomalies\n* Primary hyperparathyroidism\n* Thyroid disease\n* Use of medications that affect vitamin D or calcium metabolism\n* Inability or unwillingness to comply with the study protocol or follow-up schedule","FEMALE","18 Years","40 Years",{"count":125,"type":126},268,"ESTIMATED","INTERVENTIONAL",[129],"NA","This study is a randomized controlled trial with two parallel groups connected at Al-Thawra Modern General Hospital in Sana'a, Yemen.\n\nIt 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.\n\nPregnant 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.\n\nThe study will include singleton pregnancies between 8\\_18 weeks of gestation with serum 25-hydroxyvitamin D level below 25 ng \u002FmL . 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.",[132],"Preeclampsia","2026-06-12",{"date":135,"type":136},"2026-06-15","ACTUAL",{"date":138,"type":136},"2024-08-04",{"date":140,"type":126},"2026-09",{"name":5,"class":6},1]