Recruiting

Iron Supplementation

Sponsor:

Columbia University

Code:

NCT06042699

Conditions

Adolescent Idiopathic Scoliosis

Neuromuscular Scoliosis

Perioperative/Postoperative Complications

Iron Deficiencies

Anemia

Eligibility Criteria

Sex: All

Age: 10 - 26

Healthy Volunteers: Accepted

Interventions

Oral ferrous sulfate

Oral placebo tablet

Study Details

Brief 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

Study ID

NCT06042699

Start date

Jan 11, 2024

Status verified date

Jun, 2026

Completion date

Feb 1, 2028

Anticipated

Primary completion date

Dec 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10 - 26

Healthy Volunteers: Accepted

Inclusion Criteria:

1. 10-26 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.

Exclusion Criteria:

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.

Study Design

Enrollment

275 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

Oral ferrous sulfate

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

Oral placebo tablet

Oral placebo tablet provided as placebo comparator.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

Columbia University Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Principal Investigator:

Lisa Eisler, MD

More Information

Sponsor

Columbia University

Last update posted

Jun 26, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Columbia University on 2026-06-26.