Kids With Iron Deficiency and Scoliosis

Description

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.

Conditions

Adolescent Idiopathic Scoliosis, Neuromuscular Scoliosis, Perioperative/Postoperative Complications, Iron Deficiencies, Anemia, Spinal Fusion, Postoperative Cognitive Dysfunction

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Study Overview

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Study Details

Study overview

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.

Kids With Iron Deficiency and Scoliosis (KIDS) Study

Kids With Iron Deficiency and Scoliosis

Condition
Adolescent Idiopathic Scoliosis
Intervention / Treatment

-

Contacts and Locations

New York

Columbia University Medical Center, New York, New York, United States, 10032

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.

Ages Eligible for Study

10 Years to 26 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Columbia University,

Lisa D Eisler, MD, PRINCIPAL_INVESTIGATOR, Columbia University

Study Record Dates

2028-01-30