Actively Recruiting
Kids With Iron Deficiency and Scoliosis (KIDS) Study Evaluating Preoperative Oral Iron Supplementation to Reduce Transfusions and Improve Recovery in Adolescents Undergoing Spinal Fusion
Led by Columbia University · Updated on 2025-07-28
275
Participants Needed
1
Research Sites
6 weeks
Total Duration
On this page
Sponsors
C
Columbia University
Lead Sponsor
N
National Institute of General Medical Sciences (NIGMS)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating if preoperative oral iron supplementation can reduce complications in adolescents with scoliosis undergoing spinal fusion surgery. The study focuses on whether correcting iron deficiency before surgery lowers the need for red blood cell transfusions and helps preserve cognitive and physical abilities after surgery. This randomized controlled trial targets iron-deficient adolescents, a group at higher risk for anemia and transfusion during scoliosis surgery. Participants will be randomly assigned to receive either oral ferrous sulfate tablets containing 65 mg elemental iron or placebo tablets once daily for 3 to 6 months before surgery, depending on the time available. Those not qualifying for randomization may still participate in an observational follow-up. The study compares outcomes between the iron supplementation and placebo groups to assess effects on transfusion rates and recovery. During the study, participants will undergo screening blood tests to confirm iron deficiency and will be monitored for red blood cell transfusions within 4 to 30 days post-surgery. Cognitive function and self-reported physical capacity will be evaluated at 3 to 6 months after surgery to detect any declines. Researchers will collect data on transfusion volume and postoperative recovery, aiming to improve management strategies for this vulnerable population. Total participation spans from screening through postoperative follow-up.
CONDITIONS
Brief Title
Kids With Iron Deficiency and Scoliosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 10 and 26 years
- Diagnosis of scoliosis or kyphosis
- Ability to swallow a tablet
- Planned spinal fusion surgery approximately 6 to 24 weeks after screening
- Serum ferritin level less than or equal to 25 µg/L
You will not qualify if you...
- Taking or planning to take iron supplements on your own and unwilling to stop during the study
- Taking or planning to take iron supplements prescribed by a physician
- Hemoglobin less than 10 mg/dL if post-menarchal, less than 11 mg/dL if premenarchal or male
- Elevated C-reactive protein over 10 mg/L
- Receiving nutritional support according to medical records
- History of allergic reaction to iron supplements
- History or suspicion of non-iron deficient blood disorders
- History of iron overload conditions like hereditary hemochromatosis or hemosiderosis
- Refusal to receive red blood cell transfusions
- Current pregnancy
- Prisoner status
- Patient or parent decision against study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 to 6 months
Iron-deficient participants take daily oral ferrous sulfate or placebo tablets for 3 to 6 months prior to spinal fusion surgery as time allows.
Regular visits as needed for supplement dispensing and monitoring
Duration - 4 to 30 days
Participants undergo spinal fusion surgery and receive perioperative care including monitoring for red blood cell transfusion.
In-hospital visits during surgery and immediate recovery
Duration - 3 to 6 months
Participants are followed for assessment of neurocognitive function, physical capacity, and recovery outcomes over several months.
Periodic follow-up visits during recovery
Trial Site Locations
Total: 1 location
1
Columbia University Medical Center
New York, New York, United States, 10032
Actively Recruiting
Research Team
L
Lisa Eisler, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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