Kids With Iron Deficiency and Scoliosis
Kids With Iron Deficiency and Scoliosis (KIDS) Study
Columbia University
275 participants
Jan 11, 2024
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
Inclusion Criteria5
- years old;
- diagnosis of scoliosis or kyphosis;
- self-reported ability to swallow a tablet;
- 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;
- serum ferritin less than or equal to 25 µg/L.
Exclusion Criteria12
- taking or planning to take iron-containing supplement on patient's own volition, and not willing to stop for duration of study;
- taking or planning to take iron-containing supplement as prescribed or recommended under the care of a physician;
- Hg \<10mg/dL if post-menarchal, Hg \< 11 if premenarchal or male
- C-reactive protein \> 10 mg/L
- receiving nutritional support by report in the medical chart;
- self-reported history of hypersensitivity reaction to iron-containing supplements;
- self-reported history of or suspected non-iron deficient hematologic disorder;
- self-reported history of iron overloaded state such as hereditary hemochromatosis or hemosiderosis;
- objection to receiving red blood cell transfusions;
- current pregnancy (by self-report);
- prisoners;
- patient or parent decides against study participation.
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Interventions
Oral ferrous sulfate 325mg is used as a dietary supplement providing 65mg elemental iron.
Oral placebo tablet provided as placebo comparator.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06042699