Kids With Iron Deficiency and Scoliosis

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Adolescent Idiopathic Scoliosis, Neuromuscular Scoliosis, Perioperative/Postoperative Complications, Iron Deficiencies, Anemia, Spinal Fusion, Postoperative Cognitive Dysfunction

In brief

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.

Key facts

Study ID

NCT06042699

Run by

Columbia University

People needed

275

Starts

2024-01-11

Expected to finish

2028-02-01

Last updated by the study team

2026-06-26

Who can join

Age: 10 and older, up to 26. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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;
• serum ferritin less than or equal to 25 µg/L.

You may not qualify if…

• 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.

Where it is running

• Columbia University Medical Center — New York, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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