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New treatment option for Adolescent Idiopathic Scoliosis
Official title Kids With Iron Deficiency and Scoliosis
ClinicalTrials.gov ID: NCT06042699
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 10 to 26. Healthy volunteers may be eligible.
You may be able to join if
- 10-26 years old;
- diagnosis of scoliosis or kyphosis;
- self-reported ability to swallow a tablet;
- spinal fusion procedure planned approximately 6 to 24 weeks from an orthopedic surgical clinic visit at which patient agrees to phlebotomy for...
- serum ferritin less than or equal to 25 µg/L.
You likely can't join if
- taking or planning to take iron-containing supplement on patient's own volition, and not willing to stop for duration of study;
- taking or planning to take iron-containing supplement as prescribed or recommended under the care of a physician;
- Hg \<10mg/dL if post-menarchal, Hg \< 11 if premenarchal or male
- C-reactive protein \> 10 mg/L
- receiving nutritional support by report in the medical chart;
- self-reported history of hypersensitivity reaction to iron-containing supplements;
See the full eligibility criteria
- 10-26 years old;
- diagnosis of scoliosis or kyphosis;
- self-reported ability to swallow a tablet;
- 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;
- serum ferritin less than or equal to 25 µg/L.
- taking or planning to take iron-containing supplement on patient's own volition, and not willing to stop for duration of study;
- taking or planning to take iron-containing supplement as prescribed or recommended under the care of a physician;
- Hg \<10mg/dL if post-menarchal, Hg \< 11 if premenarchal or male
- C-reactive protein \> 10 mg/L
- receiving nutritional support by report in the medical chart;
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 10 years to 26 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.