MedTrace Logo

Kids With Iron Deficiency and Scoliosis

NCT06042699 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 275

Last updated 2025-07-28

No results posted yet for this study

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.

Conditions

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

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.

Sponsors & Collaborators

  • National Institute of General Medical Sciences (NIGMS)

    collaborator NIH

  • Columbia University

    lead OTHER

Principal Investigators

  • Lisa D Eisler, MD · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
26 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-11
Primary Completion
2027-12-15
Completion
2028-02-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06042699 on ClinicalTrials.gov