Kids With Iron Deficiency and Scoliosis (KIDS) Study

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 10
Maximum Age: 26
Healthy Volunteers: t
View:

• 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.

Locations
United States
New York
Columbia University Medical Center
RECRUITING
New York
Contact Information
Primary
Lisa Eisler, MD
ldl2113@cumc.columbia.edu
212-305-2413
Time Frame
Start Date: 2024-01-11
Estimated Completion Date: 2028-02-01
Participants
Target number of participants: 275
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Columbia University
Collaborators: National Institute of General Medical Sciences (NIGMS)

This content was sourced from clinicaltrials.gov