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Iron Supplement

Iron Supplementation for Scoliosis

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4-6 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I can swallow pills.

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I am between 12 and 19 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4-6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4-6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4-6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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

2Treatment groups

Experimental Treatment

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: 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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor

1,433 Previous Clinical Trials

2,446,984 Total Patients Enrolled

National Institute of General Medical Sciences (NIGMS)NIH

269 Previous Clinical Trials

246,837 Total Patients Enrolled

Lisa D Eisler, MDPrincipal InvestigatorColumbia University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are my qualifications compatible with the requirements of this medical experiment?

"For eligibility, patients must have an imbalance of iron levels and be between the ages of 12-19. The total number of participants sought for this trial is 275 individuals."

Answered by AI

Does this trial accept participants younger than fifty years old?

"This clinical trial's inclusion criteria stipulates that participants must be between 12 and 19 years of age. Across the entire database, 204 trials are available for people younger than 18 while 928 studies can accommodate those over 65."

Answered by AI

Are there any vacancies available for participants in this research endeavor?

"This clinical trial, posted on December 1st 2023 and last updated on September 12th 2023, is no longer seeking participants. However, 1130 other medical studies are currently looking for volunteers."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Scoliosis Iron Supplementation Study

Lisa Eisler 2024. "Scoliosis Iron Supplementation Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06042699.

All > Anemia > Scoliosis