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Recruiting NCT06042699

Kids With Iron Deficiency and Scoliosis

Conditions: Adolescent Idiopathic Scoliosis, Neuromuscular Scoliosis, Perioperative/Postoperative Complications, Iron Deficiencies, Anemia, Spinal Fusion, Postoperative Cognitive Dysfunction

Sex: All
Ages: 10 Years – 26 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 275
Sponsor: Columbia University

Location: Columbia University Medical Center New York New York

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 \ 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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06042699). StuddyBuddy aggregates publicly available trial information.