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.
10-26 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;
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
Columbia University
Lead sponsor
National Institute of General Medical Sciences (NIGMS)
Collaborator