[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100531384":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":34,"locations":44,"responsibleParty":62,"collaborators":66,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":71,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":25,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":93,"overallStatus":99,"whyStopped":25,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Princess Anna Mazowiecka Hospital, Warsaw, Poland","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"monitored group","EXPERIMENTAL","Infants in the monitored group will receive an initial dose of 1000 IU of vit D (cholecalciferol\u002F Devikap; Polpharma, Starogard Gdański, Poland).",[13],"Dietary Supplement: cholecalciferol\u002F Devikap",{"label":15,"type":16,"description":17,"interventionNames":18},"controlled group","ACTIVE_COMPARATOR","Infants in the controlled group will receive 250 IU (cholecalciferol\u002F Devikap; Polpharma, Starogard Gdański, Poland) for very low birth weight infants and 500 IU (cholecalciferol\u002F Devikap; Polpharma, Starogard Gdański, Poland) for infants weighing above 1000 g.",[13],[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DIETARY_SUPPLEMENT","cholecalciferol\u002F Devikap","Infants in the monitored group will receive an initial dose of 1000 IU of vit D. An additional 160 IU\u002Fkg of vit D is included in parenteral nutrition, as well as 150-300 IU\u002Fkg in enteral nutrition, depending on the amount and source of enteral feeding (i.e., human milk fortifiers or milk formula). At 28±2 days of age, blood samples will be obtained for 25(OH)D concentration measurement, followed by measurements every 4 weeks and\u002For 35±1 weeks of PCA. In the monitored group, vit D doses will be appropriately modified, based on 25(OH)D levels, using the scheme described in the Polish recommendation. The intake from the diet will be calculated from the second month of life.",[9],null,{"type":21,"name":22,"description":27,"armGroupLabels":28,"otherNames":25},"Infants in the controlled group will receive 250 IU for very low birth weight infants and 500 IU for infants weighing above 1000 g. An additional 160 IU\u002Fkg of vit D is included in parenteral nutrition, as well as 150-300 IU\u002Fkg in enteral nutrition, depending on the amount and source of enteral feeding (i.e., human milk fortifiers or milk formula). Infants assigned to the standard therapy group will undergo the same blood sample collection procedure as the monitored group, but without any alterations in their dosing regimen.",[15],[30],{"name":31,"affiliation":32,"role":33},"Renata Bokiniec, MD, PhD","renata.bokiniec@wum.edu.pl","STUDY_CHAIR",[35,41],{"name":36,"role":37,"phone":38,"phoneExt":39,"email":40},"Dominika M Paw, MD","CONTACT","22 596 61 36","+48","dominika.paw@wum.edu.pl",{"name":42,"role":37,"phone":25,"phoneExt":25,"email":43},"Alicja J Kołodziejczyk-Nowotarska, MD, PhD","alicja.kolodziejczyk-nowotarska@wum.edu.pl",[45],{"facility":46,"status":25,"city":47,"state":25,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Princess Anna Mazowiecka Hospital","Warsaw","00-315","Poland","PL",{"type":52,"coordinates":53},"Point",[54,55],21.01178,52.22977,{"lat":55,"lon":54},[58],{"name":59,"role":37,"phone":60,"phoneExt":39,"email":61},"Renata Bokiniec, PhD, MD","22 596 61 55","neonatologia@szpitalkarowa.pl",{"type":63,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Alicja Kołodziejczyk","MD, PhD",[67],{"name":68,"class":6},"Medical University of Warsaw","100531384","the-high-initial-dose-of-monitored-vitamin-d-supplementation-in-preterm-infants-100531384",false,"NCT06199102","The High Initial Dose of Monitored Vitamin D Supplementation in Preterm Infants.","The High Initial Dose of Monitored Vitamin D Supplementation in Preterm Infants. A Randomized Controlled Study.","HIDVID","Inclusion Criteria:\n\n* preterm infants with a gestational age of 24+0\u002F7 to 32+6\u002F7 born at our clinic\n* preterm infants with a gestational age of 24+0\u002F7 to 32+6\u002F7 outborn and admitted to our intensive care unit within 48h after delivery\n* written informed consent form caregivers for the mother and the child to participate in the study\n\nExclusion Criteria:\n\n* infants born at \\>32 weeks of gestation\n* infants with major congenital abnormalities or other severe congenital malformations\n* infants with genetic disorders (diagnosed before and after birth) deemed incompatible with survival\n* infants with diagnosed cholestasis\n* the absence of written informed consent and challenges in communication with caregivers","ALL","1 Day","2 Days",{"count":81,"type":82},130,"ESTIMATED","INTERVENTIONAL",[85],"NA","The aim of this study will be to assess the effectiveness of monitored vit D supplementation in a population of preterm infants and to identify whether the proper vit D supplementation in preterm infants can reduce the incidence of neonatal sepsis and incidence of metabolic bone disease.",[88,89,90,91,92],"Vitamin D Deficiency","Osteopenia of Prematurity","Nephrolithiasis","Metabolic Bone Disease","Late-Onset Neonatal Sepsis",[94,95,96,97,98],"vitamin D","preterm infants","osteopenia of prematurity","late-onset sepsis","metabolic bone disease","NOT_YET_RECRUITING","2024-01-09",{"date":102,"type":103},"2024-01-10","ACTUAL",{"date":105,"type":82},"2024-09-01",{"date":107,"type":82},"2027-12-31",{"name":5,"class":6},1]