NCT06042699 Kids With Iron Deficiency and Scoliosis
| NCT ID | NCT06042699 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Columbia University |
| Condition | Adolescent Idiopathic Scoliosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 275 participants |
| Start Date | 2024-01-11 |
| Primary Completion | 2027-12-15 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 275 participants in total. It began in 2024-01-11 with a primary completion date of 2027-12-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is a randomized controlled trial of preoperative oral 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 adolescents undergoing scoliosis surgery. Research Question(s)/Hypothesis(es): Primary * Iron supplementation will reduce the incidence of perioperative RBC transfusion in iron deficient scoliosis patients undergoing spinal fusion. Secondary * Iron supplementation will reduce postoperative neurocognitive functional declines in iron deficient scoliosis patients undergoing spinal fusion. * Iron supplementation will improve patient-reported physical functioning in iron deficient scoliosis patients undergoing spinal fusion.
Eligibility Criteria
Inclusion Criteria: 1. 10-26 years old; 2. diagnosis of scoliosis or kyphosis; 3. self-reported ability to swallow a tablet; 4. spinal fusion procedure planned approximately 6 to 24 weeks from an orthopedic surgical clinic visit at which patient agrees to phlebotomy for screening blood work; 5. serum ferritin less than or equal to 25 µg/L. Exclusion Criteria: 1. taking or planning to take iron-containing supplement on patient's own volition, and not willing to stop for duration of study; 2. taking or planning to take iron-containing supplement as prescribed or recommended under the care of a physician; 3. Hg \<10mg/dL if post-menarchal, Hg \< 11 if premenarchal or male 4. C-reactive protein \> 10 mg/L 5. receiving nutritional support by report in the medical chart; 6. self-reported history of hypersensitivity reaction to iron-containing supplements; 7. self-reported history of or suspected non-iron deficient hematologic disorder; 8. self-reported history of iron overloaded state such as hereditary hemochromatosis or hemosiderosis; 9. objection to receiving red blood cell transfusions; 10. current pregnancy (by self-report); 11. prisoners; 12. patient or parent decides against study participation.
Contact & Investigator
Lisa D Eisler, MD
PRINCIPAL INVESTIGATOR
Columbia University
Frequently Asked Questions
Who can join the NCT06042699 clinical trial?
This trial is open to participants of all sexes, aged 10 Years or older, up to 26 Years, studying Adolescent Idiopathic Scoliosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06042699 currently recruiting?
Yes, NCT06042699 is actively recruiting participants. Contact the research team at ldl2113@cumc.columbia.edu for enrollment information.
Where is the NCT06042699 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT06042699 clinical trial?
NCT06042699 is sponsored by Columbia University. The principal investigator is Lisa D Eisler, MD at Columbia University. The trial plans to enroll 275 participants.