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Iron Supplement

Iron Supplementation for Scoliosis (KIDS Trial)

N/A

Recruiting

Led By Lisa D Eisler, MD

Research Sponsored by Columbia University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ability to swallow a tablet

12-19 years old

Must not have

Self-reported history of or suspected non-iron deficient hematologic disorder

Self-reported history of iron overloaded state such as hereditary hemochromatosis or hemosiderosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3-6 months

Summary

This trial tests if iron deficiency increases risk of adverse outcomes in adolescents with scoliosis surgery.

Who is the study for?

Adolescents aged 12-19 with scoliosis and iron deficiency (serum ferritin ≤25 µg/L) who can swallow tablets and are scheduled for spinal fusion surgery at least 13 weeks away. Excluded are those with a history of iron overload, high inflammation markers, allergies to iron supplements, current use of iron supplements they won't stop, nutritional support recipients, transfusion objectors, pregnant individuals or prisoners.

What is being tested?

The trial is testing if taking oral ferrous sulfate (iron) before surgery can reduce the need for blood transfusions during operation and improve cognitive and physical recovery after scoliosis surgery in adolescents. Participants will be randomly given either the iron supplement or a placebo tablet.

What are the potential side effects?

Possible side effects from oral ferrous sulfate include stomach upset, constipation or diarrhea, nausea, vomiting. The placebo should have no active side effects but may cause similar symptoms due to psychological expectations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can swallow pills.

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I am between 12 and 19 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a blood disorder that is not caused by iron deficiency.

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I have a condition that causes too much iron build-up in my body.

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I refuse to receive red blood cell transfusions.

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I am taking iron supplements and cannot stop during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3-6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3-6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Percentage of Patients that experienced postoperative decline in neurocognitive function

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

Volume of perioperative RBC transfusion

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Oral ferrous sulfateExperimental Treatment1 Intervention

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.

Group II: Observational follow-upActive Control1 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.

Group III: Oral placebo tabletsPlacebo Group1 Intervention

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

0 / 6Eligibility criteria met