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RECRUITING
NCT06042699
NA

Kids With Iron Deficiency and Scoliosis

Sponsor: Columbia University

View on ClinicalTrials.gov

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 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.

Official title: Kids With Iron Deficiency and Scoliosis (KIDS) Study

Key Details

Gender

All

Age Range

10 Years - 26 Years

Study Type

INTERVENTIONAL

Enrollment

275

Start Date

2024-01-11

Completion Date

2028-02-01

Last Updated

2025-07-28

Healthy Volunteers

Yes

Interventions

DIETARY_SUPPLEMENT

Oral ferrous sulfate

Oral ferrous sulfate 325mg is used as a dietary supplement providing 65mg elemental iron.

DIETARY_SUPPLEMENT

Oral placebo tablet

Oral placebo tablet provided as placebo comparator.

Locations (1)

Columbia University Medical Center

New York, New York, United States