Kids With Iron Deficiency and Scoliosis

Launched by COLUMBIA UNIVERSITY · Sep 12, 2023

Keywords

ClinConnect Summary

This clinical trial is studying whether giving iron supplements before surgery can help teenagers with scoliosis who are low in iron. The researchers want to see if taking these supplements can lower the chances of needing a blood transfusion during or after surgery and improve how well patients think and move after the operation. They are looking for participants aged 11 to 26 who have been diagnosed with scoliosis or kyphosis and have low iron levels, as shown by a blood test. To join, candidates must be able to swallow tablets and have a spinal fusion surgery planned within a few weeks.

If you or someone you know qualifies for the study, participants will be asked to take iron supplements before their surgery and may need to attend follow-up visits to assess their recovery. It’s important to know that some individuals may not be eligible if they are already taking iron supplements, have certain health conditions, or are pregnant. Overall, the trial aims to find out if boosting iron levels can lead to better surgical outcomes for young patients with scoliosis.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 11-26 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.