Intravenous Iron for Iron Deficiency in Scoliosis

(IV-KIDS Trial)

Overseen By Lisa D Eisler, M.D.

Age: < 65

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Columbia University

Disqualifiers: High CRP, Nutritional support, Pregnancy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether administering iron through an IV (intravenous) before surgery can enhance recovery for young people undergoing spinal fusion surgery to correct scoliosis. Researchers aim to determine if ferric carboxymaltose IV can reduce the need for blood transfusions and improve mental and physical recovery post-surgery. The trial will compare the effects of the iron treatment to a placebo (a harmless substance resembling the real treatment) and include a group for observational follow-up. Suitable candidates for this trial are those aged 10-19 with scoliosis or kyphosis, scheduled for spinal fusion surgery soon, and with low iron levels. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant medical advancements.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that ferric carboxymaltose, an iron treatment administered through an IV, is generally safe and well-tolerated. Studies indicate that a single 1000 mg dose effectively treats iron deficiency anemia without causing serious side effects.

One study found that using this treatment in surgical patients with iron deficiency anemia post-surgery was both practical and safe. No major safety concerns were reported, indicating that most people tolerate the treatment well.

Overall, these findings suggest that ferric carboxymaltose is a safe option for treating iron deficiency, especially in situations where patients might lose significant blood, such as during surgery. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for scoliosis?

Unlike the standard oral iron supplements typically used for iron deficiency in scoliosis patients, ferric carboxymaltose is administered intravenously, allowing for quicker and more efficient absorption. This method bypasses the digestive system, which can minimize gastrointestinal side effects commonly associated with oral iron. Researchers are excited because this could mean faster iron level improvement, especially crucial for patients undergoing surgery, helping them recover better and faster.

What evidence suggests that intravenous ferric carboxymaltose might be an effective treatment for iron deficiency in scoliosis?

Research shows that intravenous ferric carboxymaltose, which participants in this trial may receive, effectively increases iron levels in patients undergoing surgery. Studies have found that this treatment raises hemoglobin (the protein in red blood cells that carries oxygen), serum ferritin (a protein that stores iron), and transferrin saturation (a measure of iron in the blood). Improved iron levels can reduce the need for blood transfusions during surgery, which is especially important for teenagers with scoliosis undergoing surgery. Data from multiple studies suggest that intravenous iron outperforms oral iron supplements in improving these critical blood measures. This indicates that ferric carboxymaltose may help manage iron deficiency and enhance surgical outcomes. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adolescents and young adults who are preparing for spinal fusion surgery to correct scoliosis or other spinal deformities. They must be at risk of iron deficiency and anemia but cannot have conditions that would exclude them from safely receiving intravenous iron.

Inclusion Criteria

Iron deficiency or hypoferritinemia, defined as serum ferritin less than or equal to 50 μg/L

I have been diagnosed with scoliosis or kyphosis.

I am scheduled for a spinal fusion surgery at MS-CHONY within 6 weeks.

Exclusion Criteria

Prisoners

C-reactive protein > 10 mg/L

Receiving nutritional support by report in the medical chart

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Treatment

Participants receive a one-time preoperative dose of IV ferric carboxymaltose or placebo on the morning of surgery

1 day

1 visit (in-person)

Surgery and Immediate Postoperative Care

Participants undergo spinal fusion surgery and receive perioperative care, including monitoring for RBC transfusion

4-30 days

Follow-up

Participants are monitored for changes in neurocognitive function and physical capacity postoperatively

2 to 3 months

What Are the Treatments Tested in This Trial?

Interventions

• Ferric carboxymaltose IV

Trial Overview The study tests if giving Ferric carboxymaltose (a type of IV iron) before surgery can reduce the need for blood transfusions and improve recovery compared to a saline placebo. Participants will be randomly assigned to receive either the iron treatment or placebo.

How Is the Trial Designed?

Group I: Intravenous ferric carboxymaltose Experimental Treatment 1 Intervention

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

Group II: Observational follow-up Active Control 1 Intervention

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

Group III: Intravenous normal saline Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

Association for the Advancement of Blood & Biotherapies

Collaborator

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07217873

IntraVenous Iron in Kids With Iron Deficiency and Scoliosis ... Adolescents undergoing spinal fusion surgery for scoliosis and/or kyphosis are poised to benefit from preoperative iron supplementation. Spinal ...

2. trials.arthritis.org trials.arthritis.org/trials/NCT07217873

IntraVenous Iron in Kids With Iron Deficiency and Scoliosis ... Adolescents undergoing spinal fusion surgery for scoliosis and/or kyphosis are poised to benefit from preoperative iron supplementation. Spinal fusion carries a ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04343170?term=AREA%5BConditionSearch%5D(%22Iron%20Deficiency%20Anemia%22)%20AND%20AREA%5BInterventionSearch%5D(%22Vitamin%20B12%22)&rank=7

Effect of Ultra-short-term Treatment of Patients With Iron ... Scoliosis is a condition in which there is curvature of the spine occurring in the lateral plane. It occurs in structural forms, characterized by a fixed ...

4. researchgate.net researchgate.net/publication/377352545_Effect_Of_Ultra-Short-Term_Treatment_of_Patients_with_Iron_Deficiency_Or_Anemia_Undergoing_Adolescent_Scoliosis_Correction_A_Randomized_Controlled_Prospective_Study

(PDF) Effect Of Ultra-Short-Term Treatment of Patients with ... Objectives The study aimed to evaluate the response of patients with iron deficiency or anemia undergoing adolescent scoliosis correction to ultra-short-term ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3206450/

Meta-analysis of efficacy and safety of intravenous ferric ... Intravenous ferric carboxymaltose improved mean Hb, serum ferritin, and transferrin saturation levels; the mean end-of-trial increase over oral ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40091548/

Efficacy, Safety, and Tolerability of Ferric Carboxymaltose ... This study comprehensively compares the efficacy, safety, and tolerability of two commonly used intravenous iron preparations, ferric carboxymaltose (FCM) and ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2352302616300783

Intravenous ferric carboxymaltose versus standard care in ... Postoperative intravenous ferric carboxymaltose is a feasible and pragmatic management approach in surgical patients with functional iron deficiency anaemia.

8. bmjopen.bmj.com bmjopen.bmj.com/content/14/1/e080952

Effects of ferric derisomaltose on postoperative anaemia in ... Ferric derisomaltose is a third-generation intravenous iron supplement that has been demonstrated to be effective and safe in treating iron-deficiency anaemia ...

9. bmcwomenshealth.biomedcentral.com bmcwomenshealth.biomedcentral.com/articles/10.1186/s12905-017-0506-8

Effectiveness and safety of ferric carboxymaltose compared to ... This study in conclusion demonstrates that a single dose of 1000 mg IV FCM infusion is safe and effective in the treatment of IDA in women. FCM ...