An interventional study of Oral ferrous sulfate and Oral placebo tablet in Adolescent Idiopathic Scoliosis, Neuromuscular Scoliosis and Perioperative/Postoperative Complications, sponsored by Columbia University. Recruiting at 1 site in United States. Open to participants aged 10 Years to 26 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-26.
Sponsored by Columbia University · Not applicable, Interventional, and Prevention
Among 35 studies in Postoperative Cognitive Complications with a site in United States — 6 open to participants now, 7 under way, none of them phase 3. Postoperative Cognitive Complications · United States.
Among the 35 studies in Postoperative Cognitive Complications with a site in United States, this one is the 4th largest by planned enrollment of the 22 interventional ones that give a count, is one of 3 that started in 2024, is one of 12 with no phase, and was the 29th registered.
260 studies on the registry are indexed under Postoperative Cognitive Complications; 55 are open to participants now.
This study's planned enrollment of 275 is above the median of 107 across 145 interventional studies indexed under Postoperative Cognitive Complications.
Browse Postoperative Cognitive Complications studies →6 of the 35 studies in Postoperative Cognitive Complications with a site in United States are open now.
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 33 Postoperative Cognitive Complications studies recruiting now, 21 (64%) set no upper age limit and 4 (12%) stop at 75 or younger; 2 take children under 18; 6 take healthy volunteers.
This study: 10 Years to 26 Years · all sexes · healthy volunteers too.
The full table on the hub →35 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 3 started in 2024.
Median enrollment 63 across the 22 interventional studies, 41 across the 13 observational. Of the 26 that completed or were terminated, 8 (31%) have results posted.
2 of 35 have an industry lead sponsor. The 10 most frequent:
Columbia University is the lead sponsor of 1,136 studies on the registry; 195 are open to participants now.
Of its 180 completed or terminated interventional studies of FDA-regulated products, 148 (82%) have results posted.
Columbia University has 2 studies filed under Postoperative Cognitive Complications — fewer than ten, so there is no comparison to draw.
4 of the studies in Postoperative Cognitive Complications with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06133842Beth Israel Deaconess Medical CenterCEReBral AutorEgulation in Non-cardiac SuRgery and Relationship to Postoperative DeliriUm State | 2026-12 |
| NCT07872982Scienceforbrain, UABBrainProtect-guided, Real-time Cerebral Autoregulation Monitoring and Protection of Brain During Cardiac Surgery With Cardiopulmonary Bypass Requiring Heart-lung Machine | 2027-09-30 |
| NCT06042413University of PittsburghPrediction and Prevention of Postoperative Mortality and Morbidity | 2027-10 |
| NCT07217912University of RochesterDaridorexant to Prevent Post-cardiotomy Delirium | 2027-11-01 |
Among the 35 studies in Postoperative Cognitive Complications with a site in United States, from their registry updates:
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
Secondary
Adolescents undergoing spinal fusion surgery for scoliosis are poised to benefit from preoperative iron supplementation. Spinal fusion carries a risk of large surgical blood losses and perioperative red blood cell transfusion, which are associated with adverse outcomes in this population. These patients are mostly adolescent females, a group more susceptible to iron deficiency and resulting anemia at baseline due to iron losses with menses, and who suffer an additional insult to iron stores during surgery. Nevertheless, iron status is not routinely monitored in this setting and there is no standard of care for preoperative iron supplementation. Iron is a nutritionally essential trace element important not only for red blood cell production, but also for muscle function and neurotransmitter synthesis and signaling. Therefore, the treatment of preoperative iron deficiency is an important target for optimizing hemoglobin prior to surgery, reducing transfusion rates and associated complications such as alloimmunization, and improving patient outcomes. On its own and as the primary cause of anemia, iron deficiency was identified by the investigator's team as the only risk factor for transfusion which is modifiable preoperatively.
In addition, iron supplementation is shown to alleviate impairments of physical and cognitive capacity associated with even mild forms of iron deficiency in adolescent females. A pilot study conducted at the investigator's institution identified iron deficiency in 36% of scoliosis patients prior to surgery, with preoperative iron status highly correlated with iron status during surgical recovery. Consequently, the investigator plans to examine iron deficiency as a modifiable risk factor for transfusion and impaired postoperative cognitive and physical capacity in this vulnerable population. Previous trials of brief iron interventions in high-risk adult surgical patients, mostly with unknown iron status, do not inform the care of iron deficient adolescents and were not designed to address postoperative functional outcomes. This study will therefore perform a single-center randomized controlled trial in which adolescents with scoliosis will be screened for iron deficiency (n = \~275), and iron-deficient adolescents with scoliosis (n = \~90) will be randomized to a preoperative regimen of daily oral iron or placebo, to test the hypotheses that preoperative iron supplementation 1) reduces the rate of red blood cell transfusion, 2) improves postoperative neurocognition compared to a preoperative baseline, and 3) improves patient-reported physical functioning during recovery. Results will ultimately improve outcomes in this vulnerable pediatric population and provide evidence for patient blood management approaches to reduce transfusions amid recent severe blood shortages.
260 studies on the registry are indexed under Postoperative Cognitive Complications; 55 are open to participants now.
This study's planned enrollment of 275 is above the median of 107 across 145 interventional studies indexed under Postoperative Cognitive Complications.
Browse Postoperative Cognitive Complications studies →Columbia University is the lead sponsor of 1,136 studies on the registry; 195 are open to participants now.
Of its 180 completed or terminated interventional studies of FDA-regulated products, 148 (82%) have results posted.
Compared within Postoperative Cognitive Complications, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Postoperative Complications. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Dietary Supplement: Oral ferrous sulfate
Participants will receive placebo tablets. Tablets are to be taken once daily for 3-6 months prior to surgery as time allows.
Dietary Supplement: Oral placebo tablet
Participants who do not qualify for randomization may be invited to complete study measures through postoperative follow-up as part of an observational study.
Oral ferrous sulfate 325mg is used as a dietary supplement providing 65mg elemental iron.
Oral placebo tablet provided as placebo comparator.
Incidence of perioperative RBC transfusion in iron deficient scoliosis patients undergoing spinal fusion
The patients that received a red blood cell transfusion either during procedure or postoperatively during t surgical hospitalization will be tallied.
Time frame: 4 to 30 days
Percentage of Patients that experienced postoperative decline in neurocognitive function
The Cognitive Battery of the NIH Toolbox is a brief, valid, and reliable instrument designed to provide outcome measures in epidemiologic and longitudinal research that can be used for comparisons across a wide range of studies and populations. Individual measure scores in the battery reflect Executive Function, Attention, Verbal and Nonverbal Memory, Language, Processing Speed, and Working Memory, yielding composite score. A decline of function is measured by comparing the mean change from baseline in the Cognitive Function Composite Scores in the study groups. Higher raw scores reflect higher function in the tested domains, and age-adjustment is then performed such that Age-Corrected Standard scores compare the score of the test-taker to those in the NIH Toolbox nationally representative normative sample at the same age, where a score of 100 indicates performance that was at the national average for the test-taking participant's age.
Time frame: 3-6 months
Percentage of patients that experienced postoperative decline in self-reported physical capacity
The PROMIS pediatric measures are a NIH Roadmap initiative to provide access to valid and reliable self-reported measures of health-related quality of life in children and adolescents. The PROMIS measures are scored on a T-score metric with a mean of 50 and SD of 10 in the general population in the United States. Higher PROMIS symptom scores indicate increased symptom burden, and higher PROMIS function scores indicate increased functioning. Decline would be identified through a mean change (decrease) from baseline in the Physical Functioning - Mobility scores; with secondary hypotheses for Physical Functioning - Upper Extremity, Physical Activity, and Fatigue.
Time frame: 3-6 months
Volume of perioperative RBC transfusion
The volume that each patient receives either during procedure or postoperatively during surgical hospitalization will be summed and average calculated.
Time frame: 4 to 30 days
Plan to share: No — IPD will not be shared.
No publications or documents are linked to this record.
Started Jan 2024 (actual). Primary completion is estimated for Dec 2027, 47 months after the start.
Of 62 non-industry interventional studies with no phase under Postoperative Cognitive Complications, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 33. This study's planned 47 months is above that.
Counting every sponsor, half of 62 studies reached it within 16 months; a quarter within 8 and three quarters within 33.
How these figures are worked out, and which studies are left out of them.
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Postoperative Cognitive Complications →