RecruitingNot ApplicableNCT06042699

Kids With Iron Deficiency and Scoliosis

Kids With Iron Deficiency and Scoliosis (KIDS) Study


Sponsor

Columbia University

Enrollment

275 participants

Start Date

Jan 11, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 10 YearsMax Age: 26 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Oral ferrous sulfate and Oral placebo tablet for people with adolescent idiopathic scoliosis, anemia, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTOral ferrous sulfate

Oral ferrous sulfate 325mg is used as a dietary supplement providing 65mg elemental iron.

DIETARY_SUPPLEMENTOral placebo tablet

Oral placebo tablet provided as placebo comparator.


Locations(1)

Columbia University Medical Center

New York, New York, United States

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NCT06042699


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