Kids With Iron Deficiency and Scoliosis

NCT06042699 | Recruiting

• 2 other identifiers: AAAU2577K23GM152933-01
• Study Type: interventional
• Target: 275
• Locations: 1 country
• Sites: 1

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; Spinal Fusion; Postoperative Cognitive Dysfunction

Outcome Measures

Primary Outcomes (1)

• Incidence of perioperative RBC transfusion in iron deficient scoliosis patients undergoing spinal fusion

  The patients that received a red blood cell transfusion either during procedure or postoperatively during t surgical hospitalization will be tallied.

  4 to 30 days

Secondary Outcomes (3)

• Percentage of Patients that experienced postoperative decline in neurocognitive function

  3-6 months

• Percentage of patients that experienced postoperative decline in self-reported physical capacity

  3-6 months

• Volume of perioperative RBC transfusion

  4 to 30 days

Study Arms (3)

Oral ferrous sulfate

EXPERIMENTAL

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.

Dietary Supplement: Oral ferrous sulfate

Oral placebo tablets

PLACEBO COMPARATOR

Participants will receive placebo tablets. Tablets are to be taken once daily for 3-6 months prior to surgery as time allows.

Dietary Supplement: Oral placebo tablet

Observational follow-up

NO INTERVENTION

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 DIETARY_SUPPLEMENT

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

Oral ferrous sulfate

Oral placebo tablet DIETARY_SUPPLEMENT

Oral placebo tablet provided as placebo comparator.

Oral placebo tablets

Eligibility Criteria

• Age: 10 Years - 26 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• taking or planning to take iron-containing supplement on patient's own volition, and not willing to stop for duration of study;
• taking or planning to take iron-containing supplement as prescribed or recommended under the care of a physician;
• Hg \<10mg/dL if post-menarchal, Hg \< 11 if premenarchal or male
• C-reactive protein \> 10 mg/L
• receiving nutritional support by report in the medical chart;
• self-reported history of hypersensitivity reaction to iron-containing supplements;
• self-reported history of or suspected non-iron deficient hematologic disorder;
• self-reported history of iron overloaded state such as hereditary hemochromatosis or hemosiderosis;
• objection to receiving red blood cell transfusions;
• current pregnancy (by self-report);
• prisoners;
• patient or parent decides against study participation.

Sponsors & Collaborators

• Columbia University: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

RECRUITING

MeSH Terms

Conditions

Postoperative Complications; Iron Deficiencies; Anemia; Postoperative Cognitive Complications

Interventions

ferrous sulfate

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Lisa D Eisler, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa Eisler, MD

CONTACT

212-305-2413; ldl2113@cumc.columbia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Placebo tablets will be indistinguishable from iron tablets. Group allocation will not be accessible to participants, care providers, investigators, or outcomes assessors.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology

Model Details: Double blind placebo-controlled randomized controlled trial

Study Record Dates

• First Submitted: September 12, 2023
• First Posted: September 18, 2023
• Study Start: January 11, 2024
• Primary Completion (Estimated): December 15, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)