Recruiting

Phase 2

Phase 3

Intravenous IronIntraVenous Iron in Kids With Iron Deficiency and Scoliosis Study

Sponsor:

Columbia University

Code:

NCT07217873

Conditions

Scoliosis Correction

Iron Deficiency

Transfusion Blood

Surgery Complications

Spinal Fusion

Eligibility Criteria

Sex: All

Age: 10 - 19

Healthy Volunteers: Not accepted

Interventions

Ferric carboxymaltose IV

Normal Saline (Placebo)

Study Details

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.

Conditions

Scoliosis Correction

Iron Deficiency

Transfusion Blood

Surgery Complications

Spinal Fusion

Study ID

NCT07217873

Start date

Nov 21, 2025

Status verified date

Nov, 2025

Completion date

Oct 31, 2027

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 10 - 19

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Intravenous ferric carboxymaltose

Participants will receive ferric carboxymaltose, 15mg/kg up to 750mg intravenously, on the morning of surgery.

placebo comparator: Intravenous normal saline

Patients will receive normal saline, intravenously, on the morning of surgery.

no intervention: Observational follow-up

Participants who do not qualify for randomization may be invited to complete study measures through postoperative follow-up as part of an observational study.

Interventions

Ferric carboxymaltose IV

Ferric carboxymaltose is an intravenous treatment for iron deficiency.

Normal Saline (Placebo)

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

Primary outcome measure

Incidence of perioperative RBC transfusion in iron deficient scoliosis patients undergoing spinal fusion [ Time Frame: 4-30 days ]

Central Contacts and Locations

Central contacts

Lisa D Eisler, M.D.

212-305-2413 ldl2113@cumc.columbia.edu

Locations

Columbia University Irving Medical Center

Recruiting

New York, New York, United States, 10032

More Information

Sponsor

Columbia University

Last update posted

Nov 26, 2025

Last verified

Nov, 2025

Keywords

scoliosis
iron deficiency
blood transfusion
spinal fusion
iron supplementation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Columbia University on 2025-11-26.