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Iron pills before scoliosis surgery may cut transfusions and boost recovery

NCT ID NCT06042699

Disease control Sponsor: Columbia University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether giving iron supplements to teens with iron deficiency before scoliosis surgery can reduce the need for blood transfusions and improve thinking and physical recovery afterward. About 275 participants aged 10-26 will receive either iron pills or a placebo for 6-24 weeks before their spinal fusion surgery. The goal is to see if correcting iron deficiency makes surgery safer and recovery smoother.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
oral ferrous sulfate (iron supplement)
What this could lead to
If it works, this could show that a simple iron supplement before surgery reduces the need for blood transfusions and helps teens recover better after scoliosis surgery.
What could go wrong
This is a relatively small, early-stage trial. Iron supplements may not significantly change outcomes, and some participants may experience mild side effects like stomach upset.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 275 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2024

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

10 to 26 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

adolescent idiopathic scoliosis anemia Iron Deficiencies Postoperative Cognitive Complications Postoperative Complications scoliosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Adolescent idiopathic scoliosis Anemia Iron deficiencies Neuromuscular scoliosis Perioperative/postoperative complications Postoperative cognitive dysfunction Spinal fusion

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Columbia University Medical Center

    RECRUITING

    New York, New York, 10032, United States

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