NCT07217873 IntraVenous Iron in Kids With Iron Deficiency and Scoliosis Study
| NCT ID | NCT07217873 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Columbia University |
| Condition | Scoliosis Correction |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-11-21 |
| Primary Completion | 2027-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 120 participants in total. It began in 2025-11-21 with a primary completion date of 2027-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Adolescents and young adults undergoing spinal fusion surgery for the correction of scoliosis and other spinal deformity are at high risk of perioperative iron deficiency and anemia, yet the means and evidence for optimizing iron status have not been described in this setting. The proposed study is a randomized controlled trial of preoperative intravenous 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 this vulnerable population. Building evidence for patient blood management interventions such as iron supplementation is vital to ensuring high quality care of surgical patients and may reduce unnecessary transfusions amid recent blood shortages.
Eligibility Criteria
Inclusion Criteria: * 10 -19 years old * diagnosis of scoliosis or kyphosis * scheduled for imminent spinal fusion procedure (\<6 weeks) at MS-CHONY * Iron deficiency or hypoferritinemia, defined as serum ferritin less than or equal to 50 μg/L Exclusion Criteria: * C-reactive protein \> 10 mg/L * receiving nutritional support by report in the medical chart * self-reported history of hypersensitivity reaction to iron-containing supplements * self-reported history of receiving intravenous iron supplements * self-reported history of iron overloaded state such as hereditary hemochromatosis or hemosiderosis * objection to receiving red blood cell transfusions * current pregnancy (identified by self-report or documentation of preoperative screening test in the medical record) * prisoners * patient or parent decides against study participation
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07217873 clinical trial?
This trial is open to participants of all sexes, aged 10 Years or older, up to 19 Years, studying Scoliosis Correction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07217873 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07217873 currently recruiting?
Yes, NCT07217873 is actively recruiting participants. Contact the research team at ldl2113@cumc.columbia.edu for enrollment information.
Where is the NCT07217873 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT07217873 clinical trial?
NCT07217873 is sponsored by Columbia University. The trial plans to enroll 120 participants.