[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100387968":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":15,"centralContacts":19,"locations":24,"responsibleParty":40,"collaborators":7,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":7,"eligibilityCriteria":49,"healthyVolunteers":45,"sex":50,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":7,"studyType":56,"phases":7,"briefSummary":57,"conditions":58,"keywords":7,"overallStatus":26,"whyStopped":7,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":72},{"fullName":5,"class":6},"Boston Children's Hospital","OTHER",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":13},"DIETARY_SUPPLEMENT","vitamin D3","Subjects will receive oral high dose interval vitamin D3, concurrently when they are receiving their biologic treatment for their inflammatory bowel disease every 4-8 weeks.",[14],"cholecalciferol",[16],{"name":17,"affiliation":5,"role":18},"Rebecca Gordon, MD","PRINCIPAL_INVESTIGATOR",[20],{"name":17,"role":21,"phone":22,"phoneExt":7,"email":23},"CONTACT","617-355-7476","rebecca.gordon@childrens.harvard.edu",[25],{"facility":5,"status":26,"city":27,"state":28,"zip":29,"country":30,"countryCode":31,"cosmosGeoPoint":32,"geoPoint":37,"contacts":38},"RECRUITING","Boston","Massachusetts","02115","United States","US",{"type":33,"coordinates":34},"Point",[35,36],-71.05977,42.35843,{"lat":36,"lon":35},[39],{"name":17,"role":21,"phone":7,"phoneExt":7,"email":7},{"type":18,"investigatorFullName":41,"investigatorTitle":42,"investigatorAffiliation":5,"oldNameTitle":7,"oldOrganization":7},"Rebecca Gordon","Attending Physician","100387968","high-dose-interval-vitamin-d-supplementation-in-patients-with-inflammatory-bowel-disease-receiving-biologic-therapy-100387968",false,"NCT04331639","High Dose Interval Vitamin D Supplementation in Patients With Inflammatory Bowel Disease Receiving Biologic Therapy","Implementation of High Dose Interval Vitamin D Supplementation in Patients With Inflammatory Bowel Disease Receiving Infliximab or Vedolizumab","Inclusion Criteria:\n\n* Existing diagnosis of IBD, including Crohn disease, ulcerative colitis, and indeterminate colitis\n* Receiving treatment with Infliximab or Vedolizumab every 4-8 weeks\n* Age 5-25 years old, at study entry\n* Measured serum level of 25-OHD of less than 40 ng\u002FmL in the last 4-8 weeks and no changes in vitamin D supplementation in the interim. Of note, 25-OHD levels are evaluated routinely as part of standard clinical care for IBD\n\nExclusion Criteria:\n\n* History of any underlying kidney disease\n* History of preexisting liver disease\n* History of granulomatous disease\n* Inability to take oral vitamin D3 as a pill\n* History of hypercalcemia or hypercalciuria\n* Currently, or within the past 3 months, taking an anti-epileptic medication or Lasix","ALL","5 Years","25 Years",{"count":54,"type":55},50,"ESTIMATED","OBSERVATIONAL","The investigators will be administering oral high dose interval vitamin D, concurrently when participants are receiving biologic therapy for their inflammatory bowel disease. The investigators will be collecting some additional bloodwork and questionnaires at the time of participants infusions.",[59,60,61,62],"Inflammatory Bowel Disease","Crohn Disease","Ulcerative Colitis","Vitamin D Deficiency","2025-02-27",{"date":65,"type":66},"2025-03-03","ACTUAL",{"date":68,"type":66},"2020-11-01",{"date":70,"type":55},"2025-12-31",{"name":5,"class":6},1]