Status:
RECRUITING
Kids With Iron Deficiency and Scoliosis
Lead Sponsor:
Columbia University
Collaborating Sponsors:
National Institute of General Medical Sciences (NIGMS)
Conditions:
Adolescent Idiopathic Scoliosis
Neuromuscular Scoliosis
Eligibility:
All Genders
10-26 years
Phase:
NA
Brief Summary
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 c...
Detailed Description
Adolescents undergoing spinal fusion surgery for scoliosis are poised to benefit from preoperative iron supplementation. Spinal fusion carries a risk of large surgical blood losses and perioperative r...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 11 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2028
Estimated Enrollment :
275 Patients enrolled
Trial Details
Trial ID
NCT06042699
Start Date
January 11 2024
End Date
February 1 2028
Last Update
July 28 2025
Active Locations (1)
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1
Columbia University Medical Center
New York, New York, United States, 10032