Kids With Iron Deficiency and Scoliosis (KIDS) Study
Columbia University
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.
Description
Adolescents undergoing spinal fusion surgery for scoliosis are poised to benefit from preoperative iron supplementation. Spinal fusion carries a risk of large surgical blood losses and perioperative red blood cell transfusion, which are associated with adverse outcomes in this population. These patients are mostly adolescent females, a group more susceptible to iron deficiency and resulting anemia at baseline due to iron losses with menses, and who suffer an additional insult to iron stores during surgery. Nevertheless, iron status is not routinely monitored in this setting and there is no sta…
Eligibility
- Age range
- 10–26 years
- Sex
- All
- Healthy volunteers
- Yes
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…
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.
Location
- Columbia University Medical CenterNew York, New York