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Kids With Iron Deficiency and Scoliosis

Kids With Iron Deficiency and Scoliosis (KIDS) Study

Who can join

Ages 10 to 26 · All sexes · Healthy volunteers welcome

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 a physician;
3. Hg \<10mg/dL if post-menarchal, Hg \< 11 if premenarchal or male
4. C-reactive protein \> 10 mg/L
5. receiving nutritional support by report in the medical chart;
6. self-reported history of hypersensitivity reaction to iron-containing supplements;
7. self-reported history of or suspected non-iron deficient hematologic disorder;
8. self-reported history of iron overloaded state such as hereditary hemochromatosis or hemosiderosis;
9. objection to receiving red blood cell transfusions;
10. current pregnancy (by self-report);
11. prisoners;
12. patient or parent decides against study participation.

About the study

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.

What is being tested

• Oral ferrous sulfate (dietary supplement)
• Oral placebo tablet (dietary supplement)

Sponsor: Columbia University · Participants: 275 · Started: Jan 11, 2024

Contact the study team

• Lisa Eisler, MD · Phone: 212-305-2413

Official record on ClinicalTrials.gov — NCT06042699

Locations in the U.S.

Conditions

• After Surgery
• Iron Deficiencies
• Anemia

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.