Status:
RECRUITING
IntraVenous Iron in Kids With Iron Deficiency and Scoliosis Study
Lead Sponsor:
Columbia University
Collaborating Sponsors:
Association for the Advancement of Blood & Biotherapies
Conditions:
Scoliosis Correction
Iron Deficiency
Eligibility:
All Genders
10-19 years
Phase:
PHASE2
PHASE3
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...
Detailed Description
Adolescents undergoing spinal fusion surgery for scoliosis and/or kyphosis are poised to benefit from preoperative iron supplementation. Spinal fusion carries a risk of large surgical blood losses and...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 21 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2027
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT07217873
Start Date
November 21 2025
End Date
October 31 2027
Last Update
November 26 2025
Active Locations (1)
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1
Columbia University Irving Medical Center
New York, New York, United States, 10032