NCT07217873 · Columbia University
IntraVenous Iron in Kids With Iron Deficiency and Scoliosis Study
(IV-KIDS)
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
Ferric carboxymaltose IV
Ferric carboxymaltose is an intravenous treatment for iron deficiency.
DRUG
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 measures
Incidence of perioperative RBC transfusion in iron deficient scoliosis patients undergoing spinal fusion
Time frame: 4-30 days
The patients that received a red blood cell transfusion either during procedure or postoperatively during their surgical hospitalization will be tallied.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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)
- patient or parent decides against study participation
Where
- New York, New York
Collaborators
Association for the Advancement of Blood & Biotherapies
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 26, 2025 · Source of record for eligibility and locations