Recruiting

Nutritional Program

Sponsor:

University of British Columbia

Code:

NCT07095244

Conditions

Varus-Derotation Osteotomy Surgery

Iron-deficiency Anemia

Pelvic Osteotomy Surgery

Cerebral Palsy

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Interventions

Iron Supplement

Comprehensive Nutrition Management

Study Details

Brief summary:

Varus-derotation osteotomy (VDRO) is a surgery to prevent or address hip displacement in children. Many children having this surgery have cerebral palsy or other neuromotor disorders, who have a higher rate of malnutrition, including low iron or anemia. This can affect their surgical outcomes, such as increasing their need for blood transfusions. This project aims to develop a preoperative nutritional program for VDRO patients, to improve their surgical outcomes and decrease their need for transfusions. This may include taking iron supplementation for patient with low iron or anemia. Participants will undergo a nutrition program before their surgery.

Conditions

Varus-Derotation Osteotomy Surgery

Iron-deficiency Anemia

Pelvic Osteotomy Surgery

Cerebral Palsy

Study ID

NCT07095244

Start date

Sep 1, 2025

Status verified date

May, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • All patients scheduled for VDRO and/or pelvic osteotomy surgery (prospective cohort)
  • All patients who had VDRO and/or pelvic osteotomy surgery between February 2022 and December 2024 (historical cohort)
  • Ages 0-18 years old

Note that the investigators will include patients who do or do not have a diagnosis of a neuromotor condition. The investigators may not include patients who are enrolled in other conflicting research studies.

Exclusion Criteria:

  • Patients who have undergone a major surgical intervention in the last 3 months
  • Patients who have received a nutritional intervention that includes iron testing and treatment within the last 3 months
  • Patients in whom oral/enteral iron supplementation is contraindicated
  • Patients who have a bleeding disorder
  • Patients taking erythropoietin
  • Patients who cannot read and understand English\*

  • Patients and their families who cannot read and understand English will be excluded from the study because the surveys and interviews are conducted in English. These patients will still have access to the same nutrition management and interventions as study participants.

Study Design

Enrollment

180 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Prospective (Iron Supplementation)

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.

no intervention: Historical

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.

experimental: Prospective (No Iron Supplementation)

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.

Interventions

Iron Supplement

FeraMAX Pd powder 15: NPN 80109337 FeraMAX Pd Therapeutic 150 capsules: NPN 80075623 (for an adolescent that can swallow capsules)

Comprehensive Nutrition Management

Standard nutrition care will depend on the results of the nutrition assessment, as well as underlying conditions, and will be performed regardless of iron supplementation. The intervention will be at the discretion of the dietician but may include; diet education, recommendations for vitamin and mineral supplements, optimization of tube feeds (if the child is tube fed), high protein or high energy diet education if the child is underweight, dddition of oral nutrition supplements (i.e., Pediasure or Ensure) to promote weight gain in orally fed children, discussion surrounding enteral feeding (for children who are orally fed, but severely malnourished and cannot meet their nutritional needs by mouth).

Primary outcome measure

  • Decreased incidence of blood transfusion [ Time Frame: From surgery start time to discharge from hospital. ]

Central Contacts and Locations

Central contacts

Locations

BC Children's Hospital

Recruiting

Vancouver, British Columbia, Canada, V6H 3N1

Contacts

Principal Investigator:

Teresa Skelton, MD, MPH

More Information

Sponsor

University of British Columbia

Last update posted

May 14, 2026

Last verified

May, 2026

Keywords

  • Varus-derotation osteotomy
  • Anemia
  • Iron deficiency
  • Nutrition
  • Perioperative blood management

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2026-05-14.