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Kids With Iron Deficiency and Scoliosis

Columbia University · with National Institute of General Medical Sciences (NIGMS) · NCT06042699

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 10–26 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
275
US sites recruiting
1
Study start
January 11, 2024
Record last updated
June 26, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Oral ferrous sulfate; Oral placebo tablet

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

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Recruiting US locations

  • Columbia University Medical Center

    New York, NY 10032

    Site contact: Lisa Eisler, MD · ldl2113@cumc.columbia.edu

Study contacts (from the official record)

  • Lisa Eisler, MD · 212-305-2413 · ldl2113@cumc.columbia.edu
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Kids With Iron Deficiency and Scoliosis (NCT06042699) | Bored Studies