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