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Kids With Iron Deficiency and Scoliosis
Sponsor: Columbia University
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.
Official title: Kids With Iron Deficiency and Scoliosis (KIDS) Study
Key Details
Gender
All
Age Range
10 Years - 26 Years
Study Type
INTERVENTIONAL
Enrollment
275
Start Date
2024-01-11
Completion Date
2028-02-01
Last Updated
2025-07-28
Healthy Volunteers
Yes
Conditions
Interventions
Oral ferrous sulfate
Oral ferrous sulfate 325mg is used as a dietary supplement providing 65mg elemental iron.
Oral placebo tablet
Oral placebo tablet provided as placebo comparator.
Locations (1)
Columbia University Medical Center
New York, New York, United States