[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04331639":3,"trial-entities:NCT04331639":150,"trial-summary:NCT04331639":155},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":23,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":27,"interventions":30,"primary_outcomes":37,"secondary_outcomes":42,"sex":103,"minimum_age":104,"maximum_age":105,"healthy_volunteers":106,"eligibility_criteria":107,"std_ages":121,"locations":124,"central_contacts":137,"overall_officials":141,"references":144,"see_also_links":149},"NCT04331639","P00033424","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","RECRUITING","2025-12-31","2025-02","2025-03-03","2020-11-01","Boston Children's Hospital","OTHER",true,"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.","The investigators will be administering oral high dose interval vitamin D3 concurrently when participants with inflammatory bowel disease (IBD) are receiving biologic therapy every 4-8 weeks. The investigators will collect additional bloodwork when participants are getting clinical labwork in order to assess markers of bone health and inflammation in response to vitamin D treatment. The investigators will serially assess with questionnaires associated measures, including dietary vitamin D and calcium intake, sunlight exposure, physical activity, fracture history, IBD disease activity, and overall health.",[19,20,21,22],"Inflammatory Bowel Disease","Crohn Disease","Ulcerative Colitis","Vitamin D Deficiency",[],"OBSERVATIONAL",null,[],{"count":28,"type":29},50,"ESTIMATED",[31],{"type":32,"name":33,"description":34,"otherNames":35},"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.",[36],"cholecalciferol",[38],{"measure":39,"description":40,"timeFrame":41},"vitamin D target","assessment of the percentage of patients achieving a serum 25-OHD level in the range of 40-60 ng\u002FmL","at study conclusion, up to 64 weeks",[43,46,50,53,56,59,63,66,69,73,77,80,83,87,90,93,96,99],{"measure":44,"description":45,"timeFrame":41},"change in vitamin D level","assess change in serum 25-OHD level from study entry to study conclusion",{"measure":47,"description":48,"timeFrame":49},"vitamin D binding protein","assessing vitamin D binding protein and free vitamin D","at between 12 and 24 weeks (midway through study) and up to 64 weeks (at study conclusion)",{"measure":51,"description":52,"timeFrame":49},"parathyroid hormone","assessing parathyroid hormone",{"measure":54,"description":55,"timeFrame":49},"serum safety parameter","evaluate serum calcium level",{"measure":57,"description":58,"timeFrame":49},"urine safety parameter","evaluate urinary calcium to creatinine ratio",{"measure":60,"description":61,"timeFrame":62},"bone mineral density","assess changes in bone density and body composition as assessed by DXA scan, when clinically available","at study conclusion, up to 64 weeks, when clinically available",{"measure":64,"description":65,"timeFrame":49},"markers of bone turnover","evaluating bone turnover markers such as c-telopeptide, bone specific alkaline phosphatase, osteocalcin, and N-terminal propeptide of type 1 procollagen. May do some of these, and then depending upon the results, consider doing additional analytes, as exploratory analysis.",{"measure":67,"description":68,"timeFrame":49},"inflammatory bowel disease treatment parameters","assess level of Inflixmab, including antibodies to Infliximab and Infliximab levels, when clinically available",{"measure":70,"description":71,"timeFrame":72},"cytokine measurements","evaluating pro-inflammatory and anti-inflammatory cytokine levels, specifically interleukin-17 and interferon gamma, with likely additional exploratory studies to further characterize immune response to vitamin D repletion depending upon these results.","at 0 weeks (entry into study) and up to 64 weeks (at study conclusion)",{"measure":74,"description":75,"timeFrame":76},"c-reactive protein","evaluating c-reactive protein","at all study time points, from 0 weeks (entry into study) to up to 64 weeks (at study conclusion), as clinically available",{"measure":78,"description":79,"timeFrame":76},"erythrocyte sedimentation rate","evaluating erythrocyte sedimentation rate",{"measure":81,"description":82,"timeFrame":72},"health-related quality of life questionnaire for inflammatory bowel disease","assess quality of life measures in children with inflammatory bowel disease",{"measure":84,"description":85,"timeFrame":86},"baseline questionnaire on overall health","assess overall health questionnaire","at 0 weeks (entry into study)",{"measure":88,"description":89,"timeFrame":86},"fracture history questionnaire","assess fracture history",{"measure":91,"description":92,"timeFrame":86},"food frequency questionnaire","assess calcium and vitamin D food frequency",{"measure":94,"description":95,"timeFrame":72},"physical activity questionnaire","assess physical activity level",{"measure":97,"description":98,"timeFrame":72},"sun exposure questionnaire","assess sunlight exposure",{"measure":100,"description":101,"timeFrame":102},"follow-up questionnaire on overall health","assess for any changes in inflammatory bowel disease treatment since last visit","at 4 weeks to up to 64 weeks, at all study visits except the initial visit (0 weeks)","ALL","5 Years","25 Years",false,{"inclusion":108,"exclusion":113,"raw_text":120},[109,110,111,112],"Existing diagnosis of IBD, including Crohn disease, ulcerative colitis, and indeterminate colitis","Receiving treatment with Infliximab or Vedolizumab every 4-8 weeks","Age 5-25 years old, at study entry","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",[114,115,116,117,118,119],"History of any underlying kidney disease","History of preexisting liver disease","History of granulomatous disease","Inability to take oral vitamin D3 as a pill","History of hypercalcemia or hypercalciuria","Currently, or within the past 3 months, taking an anti-epileptic medication or Lasix","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",[122,123],"CHILD","ADULT",[125],{"facility":13,"status":8,"city":126,"state":127,"zip":128,"country":129,"contacts":130,"geoPoint":134},"Boston","Massachusetts","02115","United States",[131],{"name":132,"role":133},"Rebecca Gordon, MD","CONTACT",{"lat":135,"lon":136},42.35843,-71.05977,[138],{"name":132,"role":133,"phone":139,"email":140},"617-355-7476","rebecca.gordon@childrens.harvard.edu",[142],{"name":132,"affiliation":13,"role":143},"PRINCIPAL_INVESTIGATOR",[145],{"pmid":146,"type":147,"citation":148},"41921771","DERIVED","Gordon RJ, Vishwanath V, Lavoie A, Mishra R, Rufo PA. Efficacy and Safety of Titrated High-Dose Cholecalciferol Supplementation in Children and Young Adult Patients with Inflammatory Bowel Disease. J Pediatr. 2026 Jul;294:115084. doi: 10.1016\u002Fj.jpeds.2026.115084. Epub 2026 Mar 30.",[],{"nct_id":4,"conditions":151,"biomarkers":153},[152,20,21],"Colitis of Indeterminate Type",[154],"25-OHD",{"nct_id":4,"found":15,"summary":156,"prompt_version":166},{"design":157,"status":158,"heading":159,"summary":160,"follow_up":161,"word_count":162,"commitments":163,"compensation":164,"drugs_mentioned":165},"This is an observational study with a planned enrollment of 50 participants. It is not specified if it is randomized or blinded.","completed","High Dose Vitamin D for IBD Patients on Biologic Therapy","This observational study is looking at how giving high doses of vitamin D3 affects young people (ages 5-25) with inflammatory bowel disease (IBD), including Crohn's disease and ulcerative colitis. You could be eligible if you are already receiving biologic treatments like Infliximab or Vedolizumab every 4-8 weeks and have low vitamin D levels (less than 40 ng\u002FmL). The researchers will give you oral high-dose vitamin D3 at the same time as your biologic treatment. The main goal is to see if participants reach a target vitamin D level by the end of the study, which could be up to 64 weeks. The current status of this study is unclear, and it plans to enroll 50 participants.","Your vitamin D levels will be measured at the study's conclusion, which can be up to 64 weeks.",116,"You will receive oral high-dose vitamin D3 concurrently with your regular biologic treatment every 4-8 weeks. Additional bloodwork and questionnaires will be collected during your infusion visits.","Not stated in the trial record.",[33],"v2"]