Iron Supplementation for Cerebral Palsy

(PORPOISE Trial)

Overseen By Katherine L Mason, BSc

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of British Columbia

Must not be taking: Erythropoietin

Disqualifiers: Recent surgery, Bleeding disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how iron supplementation might improve surgical outcomes for children undergoing hip surgeries due to conditions like cerebral palsy. Many of these children have low iron levels, increasing the risk of complications during surgery. The trial aims to develop a nutrition program that includes iron supplements to reduce these risks. Children scheduled for hip surgeries, particularly those with neuromotor conditions like cerebral palsy, may be suitable candidates if they have low iron levels. As an unphased trial, this study offers a unique opportunity to contribute to the development of better nutritional strategies for children with specific surgical needs.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are taking erythropoietin, you cannot participate in the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that iron supplements are generally safe for children, particularly those needing more iron. One study found that both traditional and newer iron supplements effectively treated iron deficiency anemia—when there isn't enough iron to produce healthy blood cells—without causing major issues. Another study found that a special type of iron, called liposomal iron, was easy for children to take and improved growth in those with low iron levels.

However, taking iron supplements unnecessarily can have drawbacks. Specifically, one study found that giving iron to children who don't need it might affect their growth in height and weight. Overall, when necessary, iron supplements are usually safe and beneficial. However, it's crucial to confirm their necessity before starting them. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using iron supplementation for cerebral palsy because it addresses iron deficiency, which is often overlooked in current treatments. Unlike standard therapies that focus on physical rehabilitation and medication to manage symptoms, iron supplementation targets nutritional health, potentially enhancing overall well-being and recovery. By combining iron supplements with comprehensive nutrition management, this approach may improve energy levels and reduce fatigue, offering a holistic benefit that standard treatments might not fully provide.

What evidence suggests that iron supplementation could be an effective treatment for cerebral palsy patients undergoing surgery?

Research has shown that iron supplements given to children before surgery can aid recovery and may reduce the need for blood transfusions. This trial evaluates the effects of iron supplementation in children scheduled for VDRO and/or pelvic osteotomy surgery. Participants in the "Prospective (Iron Supplementation)" arm will receive iron supplements if lab results indicate a deficiency. This is crucial for children with cerebral palsy, who often have low iron levels, potentially slowing their recovery. Although some studies have not found significant differences in iron levels between children with cerebral palsy and others, cases exist where iron has improved recovery. Specifically, iron supplements have been linked to better brain health in some children. Treating iron deficiency with supplements could enhance surgical recovery and reduce postoperative complications. ^{1 6 7 8 9}

Who Is on the Research Team?

Teresa Skelton, MD

Principal Investigator

University of British Columbia

Are You a Good Fit for This Trial?

This trial is for children with conditions like cerebral palsy undergoing hip surgery (VDRO) who may have malnutrition, low iron levels, or anemia. The study aims to help these patients improve their surgical outcomes and reduce the need for blood transfusions by providing a preoperative nutritional program.

Inclusion Criteria

I had hip surgery between February 2022 and December 2024.

Patients with or without a diagnosis of a neuromotor condition

I am scheduled for hip or pelvic bone surgery.

Exclusion Criteria

I have a bleeding disorder.

Patients who have received a nutritional intervention that includes iron testing and treatment within the last 3 months

I have not had major surgery in the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Preoperative Nutrition Program

Participants undergo a comprehensive nutritional prehabilitation program, including iron deficiency anemia assessment and management, before VDRO surgery.

Up to 12 months

Multiple visits (in-person and virtual)

Surgery and Perioperative Care

Participants undergo VDRO surgery with perioperative nutritional management to improve surgical outcomes and decrease the need for blood transfusions.

Hospital stay from surgery start to discharge

Inpatient stay

Follow-up

Participants are monitored for safety and effectiveness after surgery, including resolution of anemia and increased iron levels.

12 months post-op

Regular follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• Iron Supplement

Trial Overview The intervention being tested is a comprehensive nutrition management program that includes iron supplementation. This approach is designed to address malnutrition and deficiencies such as anemia in pediatric patients before they undergo VDRO surgery.

How Is the Trial Designed?

Group I: Prospective (No Iron Supplementation) Experimental Treatment 1 Intervention

Patients scheduled for VDRO and/or pelvic osteotomy surgery who are aged 0 to 18 years old (n = 50-60). Note that the investigators will include patients who do or do not have a diagnosis of a neuromotor condition. All patients will be evaluated by the dietitian and have screening lab work to evaluate for iron deficiency at initial consultation. If lab results show adequate iron levels, patients will be allocated to the "no iron supplementation" arm and will only receive comprehensive nutrition management, without an iron supplementation prescription.

Group II: Prospective (Iron Supplementation) Experimental Treatment 2 Interventions

Patients scheduled for VDRO and/or pelvic osteotomy surgery who are aged 0 to 18 years old (n = 50-60). Note that the investigators will include patients who do or do not have a diagnosis of a neuromotor condition. All patients will be evaluated by the dietitian and have screening lab work to evaluate for iron deficiency at initial consultation. If lab results show that iron supplementation is required, patients will be allocated to the iron supplementation arm and will receive a prescription for iron supplementation, education on non-pharmacological methods to enhance iron intake and comprehensive nutrition management.

Group III: Historical Active Control 1 Intervention

All patients who had VDRO and/or pelvic osteotomy surgery between February 2022 and December 2024 who are aged 0 to 18 years old (n = 100-120). These participants will be enrolled as comparators and receive no intervention, as their surgery has passed.

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

BC Children's Hospital Research Institute

Collaborator

Trials

14

Recruited

2,800+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11721373/

Assessment of Iron Metabolism and Inflammation in Children ... The median value of iron in the group with cerebral palsy was 52 (4–194). According to this value, patients with CP were divided into two groups ...

2. nature.com nature.com/articles/s41598-023-45697-w

Association between Cu/Zn/Iron/Ca/Mg levels and cerebral ... No significant differences of Cu, iron and Ca levels between CP cases and controls among Caucasians (SMD = − 0.188, 95% CI − 0.412 to 0.037, P = ...

3. psychiatryonline.org psychiatryonline.org/doi/10.1176/appi.neuropsych.20230081

Systematic Review, Meta-Analysis, and Qualitative Synthesis Nonsignificant improvements on the CPRS and CTRS were observed among participants treated with iron compared those receiving placebo (42).

4. clinicaltrials.gov clinicaltrials.gov/study/NCT07095244

Pediatric Outcomes and Recovery With Peri-Operative Iron ... This project aims to develop a preoperative nutritional program for VDRO patients, to improve their surgical outcomes and decrease their need for transfusions.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8760203/

Neurological development and iron supplementation in ... Our data show that LPT neonates who received iron supplementation during the first 6 months of life achieved significantly better neurological outcomes at 12- ...

6. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0271993

Dietary and nutritional interventions in children with cerebral ... Some promising dietary and nutritional interventions may promote important clinical improvements for patients with cerebral palsy.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2589537023000305

A novel nano-iron supplement versus standard treatment ... Primary outcomes​​ Both iron supplement formulations were equally effective at correcting IDA in comparison with the placebo group. IDA treatment response was ...

8. nature.com nature.com/articles/s41390-025-04204-9

Interventional impact of liposomal iron on iron-deficient ... Liposomal iron showed, in addition to good efficacy and tolerability, a favorable impact on the development and growth of iron-deficient children.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3311916/

Iron supplementation in early childhood: health benefits and ... Evidence suggests that iron supplementation in young children without iron deficiency may jeopardize optimal height and weight gains. Morbidity due to ...