Kids With Iron Deficiency and Scoliosis

Part of paid clinical trials in New York, New York.

Sponsor
Columbia University
Study ID
NCT06042699
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
10 Years - 26 Years
Healthy Volunteers
Accepted

Interventions

  • Oral ferrous sulfate — DIETARY_SUPPLEMENT
    Oral ferrous sulfate 325mg is used as a dietary supplement providing 65mg elemental iron.
  • Oral placebo tablet — DIETARY_SUPPLEMENT
    Oral placebo tablet provided as placebo comparator.

Study Details

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.

Key Dates

Start date
Jan 11, 2024
Status verified
Jul 2025
Primary completion
Dec 15, 2027
Completion
Feb 1, 2028

Study Design

Enrollment
275 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Oral ferrous sulfate
    Participants will receive oral ferrous sulfate tablets, 325mg (65mg elemental iron). Tablets are to be taken once daily for 3-6 months prior to surgery as time allows.
  • Placebo Comparator: Oral placebo tablets
    Participants will receive placebo tablets. Tablets are to be taken once daily for 3-6 months prior to surgery as time allows.
  • No Intervention: Observational follow-up
    Participants who do not qualify for randomization may be invited to complete study measures through postoperative follow-up as part of an observational study.

Primary Outcome Measure

Incidence of perioperative RBC transfusion in iron deficient scoliosis patients undergoing spinal fusion [ Time Frame: 4 to 30 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Columbia University Medical CenterNew YorkNew York10032
Lisa Eisler, MD
[email protected]
Lisa Eisler, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Columbia University Medical Center· New York, NY

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