Iron Supplementation for Scoliosis
(KIDS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot take iron supplements on your own or as prescribed by a doctor during the study.
Is iron supplementation generally safe for humans?
Iron supplements like ferrous sulfate are generally safe for humans, but they can cause side effects like stomach upset and, in rare cases, more serious issues like mucosal injury in the digestive tract. Some studies found that newer formulations may have fewer side effects compared to traditional ferrous sulfate tablets.12345
How does the drug ferrous sulfate differ from other treatments for scoliosis?
Ferrous sulfate is unique for scoliosis treatment as it involves oral iron supplementation, which is not a standard approach for this condition. Unlike typical scoliosis treatments that focus on physical therapy or surgery, this trial explores the potential role of iron in managing scoliosis, which is novel and not commonly practiced.12678
Who Is on the Research Team?
Lisa D Eisler, MD
Principal Investigator
Columbia University
Are You a Good Fit for This Trial?
Adolescents aged 12-19 with scoliosis and iron deficiency (serum ferritin ≤25 µg/L) who can swallow tablets and are scheduled for spinal fusion surgery at least 13 weeks away. Excluded are those with a history of iron overload, high inflammation markers, allergies to iron supplements, current use of iron supplements they won't stop, nutritional support recipients, transfusion objectors, pregnant individuals or prisoners.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Preoperative Treatment
Participants receive daily oral iron or placebo tablets for 3-6 months prior to surgery
Surgery and Immediate Postoperative
Participants undergo spinal fusion surgery and are monitored for perioperative RBC transfusion
Follow-up
Participants are monitored for postoperative neurocognitive and physical capacity declines
What Are the Treatments Tested in This Trial?
Interventions
- Oral ferrous sulfate
- Oral placebo tablet
Oral ferrous sulfate is already approved in United States, European Union, Canada for the following indications:
- Iron deficiency anemia
- Preoperative iron supplementation for surgical procedures
- Iron deficiency anemia
- Preoperative iron supplementation for surgical procedures
- Iron deficiency anemia
- Preoperative iron supplementation for surgical procedures
Find a Clinic Near You
Who Is Running the Clinical Trial?
Columbia University
Lead Sponsor
National Institute of General Medical Sciences (NIGMS)
Collaborator