Iron supplementation for adolescents with scoliosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effects of preoperative oral iron supplementation on adolescents with scoliosis who are iron deficient. The study aims to determine if iron supplementation can reduce the need for red blood cell transfusions and improve postoperative cognitive and physical functioning in these patients undergoing spinal fusion surgery. Participants will be randomly assigned to receive either iron supplements or a placebo, and their outcomes will be monitored to assess the impact of iron on surgical recovery. The trial focuses on a population that is particularly vulnerable to iron deficiency due to factors such as menstruation and the demands of surgery.

Why it matters

Who can join: the full rules

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.

Where it's running

• Columbia University Medical Center
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Lisa D Eisler, MD — Columbia University
• Study coordinator: Lisa Eisler, MD
• Email: ldl2113@cumc.columbia.edu
• Phone: 212-305-2413

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.