RECRUITING

Kids With Iron Deficiency and Scoliosis

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Kids With Iron Deficiency and Scoliosis (KIDS) Study

Quick Facts

Study Start:2024-01-11

Study Completion:2028-01-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06042699

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:10 Years to 26 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion Criteria
1. 11-26 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.	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.

Inclusion Criteria

Exclusion Criteria

1. 11-26 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.

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.

Contacts and Locations

Study Contact

Lisa Eisler, MD

CONTACT

212-305-2413

ldl2113@cumc.columbia.edu

Principal Investigator

Lisa D Eisler, MD

PRINCIPAL_INVESTIGATOR

Columbia University

Study Locations (Sites)

Columbia University Medical Center

New York, New York, 10032

United States

Collaborators and Investigators

Sponsor: Columbia University

Lisa D Eisler, MD, PRINCIPAL_INVESTIGATOR, Columbia University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-11

Study Completion Date2028-01-30

Study Record Updates

Study Start Date2024-01-11

Study Completion Date2028-01-30

Terms related to this study

Additional Relevant MeSH Terms

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