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New treatment option for Scoliosis Correction
Official title IntraVenous Iron in Kids With Iron Deficiency and Scoliosis Study
ClinicalTrials.gov ID: NCT07217873
What this study is testing
What is Ferric carboxymaltose IV?
Ferric carboxymaltose IV is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for scoliosis correction.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 10 to 19
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 10 years to 19 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.