Kids With Iron Deficiency and Scoliosis (KIDS)

Kids With Iron Deficiency and Scoliosis (KIDS) Study

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.

Study Overview

• Status: Recruiting
• Conditions: Anemia; Postoperative Cognitive Dysfunction; Adolescent Idiopathic Scoliosis; Spinal Fusion; Perioperative/Postoperative Complications; Neuromuscular Scoliosis; Iron Deficiencies
• Intervention / Treatment: Dietary supplement: Oral ferrous sulfate; Dietary supplement: Oral placebo tablet

Detailed Description

Adolescents undergoing spinal fusion surgery for scoliosis are poised to benefit from preoperative iron supplementation. Spinal fusion carries a risk of large surgical blood losses and perioperative red blood cell transfusion, which are associated with adverse outcomes in this population. These patients are mostly adolescent females, a group more susceptible to iron deficiency and resulting anemia at baseline due to iron losses with menses, and who suffer an additional insult to iron stores during surgery. Nevertheless, iron status is not routinely monitored in this setting and there is no standard of care for preoperative iron supplementation. Iron is a nutritionally essential trace element important not only for red blood cell production, but also for muscle function and neurotransmitter synthesis and signaling. Therefore, the treatment of preoperative iron deficiency is an important target for optimizing hemoglobin prior to surgery, reducing transfusion rates and associated complications such as alloimmunization, and improving patient outcomes. On its own and as the primary cause of anemia, iron deficiency was identified by the investigator's team as the only risk factor for transfusion which is modifiable preoperatively.

In addition, iron supplementation is shown to alleviate impairments of physical and cognitive capacity associated with even mild forms of iron deficiency in adolescent females. A pilot study conducted at the investigator's institution identified iron deficiency in 36% of scoliosis patients prior to surgery, with preoperative iron status highly correlated with iron status during surgical recovery. Consequently, the investigator plans to examine iron deficiency as a modifiable risk factor for transfusion and impaired postoperative cognitive and physical capacity in this vulnerable population. Previous trials of brief iron interventions in high-risk adult surgical patients, mostly with unknown iron status, do not inform the care of iron deficient adolescents and were not designed to address postoperative functional outcomes. This study will therefore perform a single-center randomized controlled trial in which adolescents with scoliosis will be screened for iron deficiency (n = ~275), and iron-deficient adolescents with scoliosis (n = ~90) will be randomized to a preoperative regimen of daily oral iron or placebo, to test the hypotheses that preoperative iron supplementation 1) reduces the rate of red blood cell transfusion, 2) improves postoperative neurocognition compared to a preoperative baseline, and 3) improves patient-reported physical functioning during recovery. Results will ultimately improve outcomes in this vulnerable pediatric population and provide evidence for patient blood management approaches to reduce transfusions amid recent severe blood shortages.

• Study Type: Interventional
• Enrollment (Estimated): 275
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lisa Eisler, MD; Phone Number: 212-305-2413; Email: ldl2113@cumc.columbia.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Recruiting
      • Columbia University Medical Center
      • Principal Investigator: Lisa Eisler, MD
      • Contact: Lisa Eisler, MD; Email: ldl2113@cumc.columbia.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Dietary supplement: Oral ferrous sulfate; Oral ferrous sulfate 325mg is used as a dietary supplement providing 65mg elemental iron.
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.	Dietary supplement: Oral placebo tablet; Oral placebo tablet provided as placebo comparator.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Volume of perioperative RBC transfusion	The volume that each patient receives either during procedure or postoperatively during surgical hospitalization will be summed and average calculated.	4 to 30 days
Percentage of Patients that experienced postoperative decline in neurocognitive function	The Cognitive Battery of the NIH Toolbox is a brief, valid, and reliable instrument designed to provide outcome measures in epidemiologic and longitudinal research that can be used for comparisons across a wide range of studies and populations. Individual measure scores in the battery reflect Executive Function, Attention, Verbal and Nonverbal Memory, Language, Processing Speed, and Working Memory, yielding composite score. A decline of function is measured by comparing the mean change from baseline in the Cognitive Function Composite Scores in the study groups. Higher raw scores reflect higher function in the tested domains, and age-adjustment is then performed such that Age-Corrected Standard scores compare the score of the test-taker to those in the NIH Toolbox nationally representative normative sample at the same age, where a score of 100 indicates performance that was at the national average for the test-taking participant's age.	3-6 months
Percentage of patients that experienced postoperative decline in self-reported physical capacity	The PROMIS pediatric measures are a NIH Roadmap initiative to provide access to valid and reliable self-reported measures of health-related quality of life in children and adolescents. The PROMIS measures are scored on a T-score metric with a mean of 50 and SD of 10 in the general population in the United States. Higher PROMIS symptom scores indicate increased symptom burden, and higher PROMIS function scores indicate increased functioning. Decline would be identified through a mean change (decrease) from baseline in the Physical Functioning - Mobility scores; with secondary hypotheses for Physical Functioning - Upper Extremity, Physical Activity, and Fatigue.	3-6 months

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: National Institute of General Medical Sciences (NIGMS)
• Investigators: Principal Investigator: Lisa D Eisler, MD, Columbia University

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2024
• Primary Completion (Estimated): December 15, 2027
• Study Completion (Estimated): February 1, 2028

Study Registration Dates

• First Submitted: September 12, 2023
• First Submitted That Met QC Criteria: September 12, 2023
• First Posted (Actual): September 18, 2023

Study Record Updates

• Last Update Posted (Actual): July 28, 2025
• Last Update Submitted That Met QC Criteria: July 25, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Mental Disorders; Pathologic Processes; Metabolic Diseases; Neurocognitive Disorders; Hematologic Diseases; Cognition Disorders; Spinal Diseases; Anemia; Iron Metabolism Disorders; Anemia, Hypochromic; Spinal Curvatures; Postoperative Cognitive Complications; Iron Deficiencies; Cognitive Dysfunction; Anemia, Iron-Deficiency; Scoliosis; Postoperative Complications
• Other Study ID Numbers: AAAU2577; K23GM152933-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes