Scoliosis Iron Supplementation Study

Anemia Clinical Trial

Official title:

Study of Iron Supplementation in Adolescents Undergoing Scoliosis Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06042699
• Other study ID #: AAAU2577
• Secondary ID: K23GM152933-01
• Status: Recruiting
• Phase: N/A
• Start date: January 11, 2024
• Est. completion date: January 30, 2028

Study information

• Verified date: January 2024
• Source: Columbia University
• Contact: Lisa Eisler, MD
• Phone: 212-305-2413
• Email: ldl2113[@]cumc.columbia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 275
• Est. completion date: January 30, 2028
• Est. primary completion date: November 30, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 19 Years

Eligibility

Inclusion Criteria:

• 12-19 years old
• diagnosis of scoliosis
• ability to swallow a tablet
• spinal fusion procedure planned at least 13 weeks from when patient agrees to phlebotomy for screening blood work
• serum ferritin less than or equal to 25 µg/L

Exclusion Criteria:

• taking or planning to take iron-containing supplement under the direction of a health care provider, or under patient's own volition and and not willing to stop for duration of study
• C-reactive protein > 10 mg/L
• receiving nutritional support
• 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

Related Conditions & MeSH terms

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

Intervention

Dietary Supplement:
• 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.

Locations

Country	Name	City	State
United States	Columbia University Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	National Institute of General Medical Sciences (NIGMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	4-6 months
Secondary	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.	4-6 months
Secondary	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