RecruitingPhase 2Phase 3NCT07217873

IntraVenous Iron in Kids With Iron Deficiency and Scoliosis Study

IntraVenous Iron in Kids With Iron Deficiency and Scoliosis


Sponsor

Columbia University

Enrollment

120 participants

Start Date

Nov 21, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 10 YearsMax Age: 19 Years

Inclusion Criteria4

  • 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 Criteria9

  • 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

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Interventions

DRUGFerric carboxymaltose IV

Ferric carboxymaltose is an intravenous treatment for iron deficiency.

DRUGNormal Saline (Placebo)

Normal saline is the recommended diluent for ferric carboxymaltose, and on its own serves as the placebo control for this study.


Locations(1)

Columbia University Irving Medical Center

New York, New York, United States

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NCT07217873


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