Actively Recruiting
Kids With Iron Deficiency and Scoliosis
Led by Columbia University · Updated on 2025-07-28
275
Participants Needed
1
Research Sites
211 weeks
Total Duration
On this page
Sponsors
C
Columbia University
Lead Sponsor
N
National Institute of General Medical Sciences (NIGMS)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Kids With Iron Deficiency and Scoliosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 10 and 26 years
- Diagnosis of scoliosis or kyphosis
- Ability to swallow a tablet
- Planned spinal fusion surgery about 6 to 24 weeks after screening blood test
- Serum ferritin level less than or equal to 25 g/L
You will not qualify if you...
- Taking or planning to take iron supplements on their own and unwilling to stop during the study
- Taking or planning to take iron supplements prescribed by a doctor
- Hemoglobin less than 10 mg/dL if post-menarchal, less than 11 mg/dL if premenarchal or male
- C-reactive protein level greater than 10 mg/L
- Receiving nutritional support according to medical records
- History of allergic reaction to iron supplements
- History or suspicion of blood disorders not caused by iron deficiency
- History of iron overload conditions such as hereditary hemochromatosis or hemosiderosis
- Refusal to receive red blood cell transfusions
- Current pregnancy
- Prisoners
- Patient or parent decides against study participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Columbia University Medical Center
New York, New York, United States, 10032
Actively Recruiting
Research Team
L
Lisa Eisler, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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