Iron supplementation for adolescents with scoliosis
Kids With Iron Deficiency and Scoliosis (KIDS) Study
This study tests if giving iron supplements to teenagers with scoliosis before their surgery can help them recover better and need fewer blood transfusions.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 275 (estimated) |
| Ages | 10 Years to 26 Years |
| Sex | All |
| Sponsor | Columbia University Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06042699 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of preoperative oral iron supplementation on adolescents with scoliosis who are iron deficient. The study aims to determine if iron supplementation can reduce the need for red blood cell transfusions and improve postoperative cognitive and physical functioning in these patients undergoing spinal fusion surgery. Participants will be randomly assigned to receive either iron supplements or a placebo, and their outcomes will be monitored to assess the impact of iron on surgical recovery. The trial focuses on a population that is particularly vulnerable to iron deficiency due to factors such as menstruation and the demands of surgery.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 11-26 with a diagnosis of scoliosis or kyphosis and low serum ferritin levels.
Not a fit: Patients who are not iron deficient or those with certain hematologic disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve surgical outcomes and recovery for adolescents with scoliosis who are iron deficient.
How similar studies have performed: Previous studies have indicated that addressing iron deficiency can improve outcomes in surgical populations, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
New York, New York
- Columbia University Medical Center — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Lisa D Eisler, MD — Columbia University
- Study coordinator: Lisa Eisler, MD
- Email: ldl2113@cumc.columbia.edu
- Phone: 212-305-2413
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.