[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100519373":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":34,"centralContacts":38,"locations":44,"responsibleParty":61,"collaborators":64,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":76,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":24,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":24,"overallStatus":47,"whyStopped":24,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Columbia University","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Oral ferrous sulfate","EXPERIMENTAL","Participants will receive oral ferrous sulfate tablets, 325mg (65mg elemental iron). Tablets are to be taken once daily for 3-6 months prior to surgery as time allows.",[13],"Dietary Supplement: Oral ferrous sulfate",{"label":15,"type":16,"description":17,"interventionNames":18},"Oral placebo tablets","PLACEBO_COMPARATOR","Participants will receive placebo tablets. Tablets are to be taken once daily for 3-6 months prior to surgery as time allows.",[19],"Dietary Supplement: Oral placebo tablet",{"label":21,"type":22,"description":23,"interventionNames":24},"Observational follow-up","NO_INTERVENTION","Participants who do not qualify for randomization may be invited to complete study measures through postoperative follow-up as part of an observational study.",null,[26,30],{"type":27,"name":9,"description":28,"armGroupLabels":29,"otherNames":24},"DIETARY_SUPPLEMENT","Oral ferrous sulfate 325mg is used as a dietary supplement providing 65mg elemental iron.",[9],{"type":27,"name":31,"description":32,"armGroupLabels":33,"otherNames":24},"Oral placebo tablet","Oral placebo tablet provided as placebo comparator.",[15],[35],{"name":36,"affiliation":5,"role":37},"Lisa D Eisler, MD","PRINCIPAL_INVESTIGATOR",[39],{"name":40,"role":41,"phone":42,"phoneExt":24,"email":43},"Lisa Eisler, MD","CONTACT","212-305-2413","ldl2113@cumc.columbia.edu",[45],{"facility":46,"status":47,"city":48,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Columbia University Medical Center","RECRUITING","New York","10032","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-74.00597,40.71427,{"lat":56,"lon":55},[59,60],{"name":40,"role":41,"phone":24,"phoneExt":24,"email":43},{"name":40,"role":37,"phone":24,"phoneExt":24,"email":24},{"type":37,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Lisa Eisler","Assistant Professor of Anesthesiology",[65],{"name":66,"class":67},"National Institute of General Medical Sciences (NIGMS)","NIH","100519373","kids-with-iron-deficiency-and-scoliosis-100519373",false,"NCT06042699","Kids With Iron Deficiency and Scoliosis","Kids With Iron Deficiency and Scoliosis (KIDS) Study","KIDS","Inclusion Criteria:\n\n1. 10-26 years old;\n2. diagnosis of scoliosis or kyphosis;\n3. self-reported ability to swallow a tablet;\n4. spinal fusion procedure planned approximately 6 to 24 weeks from an orthopedic surgical clinic visit at which patient agrees to phlebotomy for screening blood work;\n5. serum ferritin less than or equal to 25 µg\u002FL.\n\nExclusion Criteria:\n\n1. taking or planning to take iron-containing supplement on patient's own volition, and not willing to stop for duration of study;\n2. taking or planning to take iron-containing supplement as prescribed or recommended under the care of a physician;\n3. Hg \\\u003C10mg\u002FdL if post-menarchal, Hg \\\u003C 11 if premenarchal or male\n4. C-reactive protein \\> 10 mg\u002FL\n5. receiving nutritional support by report in the medical chart;\n6. self-reported history of hypersensitivity reaction to iron-containing supplements;\n7. self-reported history of or suspected non-iron deficient hematologic disorder;\n8. self-reported history of iron overloaded state such as hereditary hemochromatosis or hemosiderosis;\n9. objection to receiving red blood cell transfusions;\n10. current pregnancy (by self-report);\n11. prisoners;\n12. patient or parent decides against study participation.",true,"ALL","10 Years","26 Years",{"count":81,"type":82},275,"ESTIMATED","INTERVENTIONAL",[85],"NA","This study is a randomized controlled trial of preoperative oral iron supplementation, to identify whether iron deficiency is a modifiable risk factor for adverse surgical outcomes such as red blood cell transfusion and diminished postoperative cognitive and physical capacity in adolescents undergoing scoliosis surgery.\n\nResearch Question(s)\u002FHypothesis(es):\n\nPrimary\n\n* Iron supplementation will reduce the incidence of perioperative RBC transfusion in iron deficient scoliosis patients undergoing spinal fusion.\n\nSecondary\n\n* Iron supplementation will reduce postoperative neurocognitive functional declines in iron deficient scoliosis patients undergoing spinal fusion.\n* Iron supplementation will improve patient-reported physical functioning in iron deficient scoliosis patients undergoing spinal fusion.",[88,89,90,91,92,93,94],"Adolescent Idiopathic Scoliosis","Neuromuscular Scoliosis","Perioperative\u002FPostoperative Complications","Iron Deficiencies","Anemia","Spinal Fusion","Postoperative Cognitive Dysfunction","2026-06-25",{"date":97,"type":98},"2026-06-26","ACTUAL",{"date":100,"type":98},"2024-01-11",{"date":102,"type":82},"2028-02-01",{"name":5,"class":6},1]