An interventional study of Iron Supplement and Comprehensive Nutrition Management in Varus-Derotation Osteotomy Surgery, Iron-deficiency Anemia and Pelvic Osteotomy Surgery, sponsored by University of British Columbia. Recruiting at 1 site in Canada. Open to participants aged 0 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-05-14.
Sponsored by University of British Columbia · Not applicable, Interventional, and Prevention
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.
Purpose:
The investigators aim to establish a multidisciplinary pathway for all patients scheduled for varus-derotation osteotomy (VDRO) surgery that incorporates comprehensive nutrition management and iron deficiency anemia assessment and management. The goal is to determine whether patients with nutritional optimization will experience improved care, including a decreased risk of adverse outcomes and improved surgical outcomes.
Hypothesis:
The primary hypothesis is that a comprehensive nutritional prehabilitation intervention for iron deficiency anemia before pediatric varus-derotational osteotomy (VDRO) surgery will decrease the risk blood transfusion, as shown by a lower incidence of blood transfusions, during the preoperative period. The investigators also aim to show that this program will improve other perioperative surgical outcomes and will be feasible and acceptable to families.
Justification:
VDRO, a surgical procedure designed to prevent or address hip displacement, is a lengthy procedure (>4 hours), with risk of blood transfusion from 10-25%. VDRO patients often present with complex medical conditions and require multidisciplinary care. Malnutrition contributes to morbidity but is rarely highlighted by the perioperative team. Similarly, while patient blood management programs are standard perioperative care for adults, their implementation in pediatrics is limited. Estimates of iron-deficiency anemia in Canadian children range from 12-64%, without considering medically complex patients at high risk of malnutrition. Preoperative anemia raises the risk of in-hospital mortality for pediatric surgical patients. BC Children's Hospital treats 30-35 VDRO patients annually. The investigators aim to establish a multidisciplinary nutritional and prehabilitation program for elective VDRO patients (with and without neuromotor conditions) that includes comprehensive nutrition and iron deficiency anemia management.
Objectives:
(1) Study the integration of blood management into the nutritional care of patients having VDRO surgery and determine whether it improves perioperative outcomes; (2) evaluate the program's operational feasibility and its acceptability among patients' families; (3) apply the findings to other elective surgical interventions, such as neuromuscular scoliosis surgery.
Research Design:
The investigators will conduct a prospective observational study to evaluate this comprehensive nutritional prehabilitation program over a 24-month period and compare outcomes against a historical cohort from February 2022 to December 2024 using propensity score matching. The primary outcome will be the percentage of patients transfused during the perioperative stay. Secondary perioperative outcomes will include anemia, iron levels, length of hospital stay, and surgical complications such as pressure sores. The investigators will recruit all patients 0-18 years scheduled to undergo VDRO and/or pelvic osteotomy, unless they have undergone a surgical intervention or received a nutritional intervention that includes iron within the previous 3 months. All patients will be evaluated by the dietitian and have screening lab work to evaluate for iron deficiency at initial consultation. If required, patients will receive a prescription for iron supplementation and education on non-pharmacological methods to enhance iron intake. Longitudinal online surveys will assess compliance/tolerance and family satisfaction with the program. Further feedback will be obtained in optional semi-structured interviews.
Iron Supplementation Intevntion:
Feramax (or other iron polysaccharide complex) will be prescribed as it is most used in practice due to its fewer gastrointestinal side effects, ability to be taken with food, and lack of requirement for stomach acid for absorption, making it suitable for patients receiving gastrojejunostomy feedings. The typical dose of iron for pediatric patients with deficiency is 3-6 mg/kg, up to a maximum of 150 mg/day. Other possible nutritional interventions may include recommending supplements (most commonly calcium/Vitamin D and occasionally a multivitamin), optimizing tube feeds, and providing dietary education.
Standard Nutrition Intervention:
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 components of the following non-exhaustive list.
Statistical Analysis The investigators will recruit a convenience sample of participants over a two-year period (n\~50); the investigators will propensity-score match each prospective participant to two historical controls based on age, sex, gross motor function classification system score, ASA physical status score, and procedure booking code. Transfusion rates between the baseline period and the intervention period will be compared using Fisher's exact test. Semi-structured interviews will be analyzed using a grounded theory-based qualitative approach.
644 studies on the registry are indexed under Anemia, Iron-Deficiency; 105 are open to participants now.
This study's planned enrollment of 180 is above the median of 100 across 503 interventional studies indexed under Anemia, Iron-Deficiency.
Browse Anemia, Iron-Deficiency studies →University of British Columbia is the lead sponsor of 1,309 studies on the registry; 253 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
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 cannot read and understand English*
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.
Dietary Supplement: Iron Supplement · Dietary Supplement: Comprehensive Nutrition Management
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.
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.
Dietary Supplement: Comprehensive Nutrition Management
FeraMAX Pd powder 15: NPN 80109337 FeraMAX Pd Therapeutic 150 capsules: NPN 80075623 (for an adolescent that can swallow capsules)
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).
Also known as: Standard Nutrition Care
Decreased incidence of blood transfusion
A comprehensive nutritional prehabilitation intervention for iron deficiency anemia before pediatric VDRO surgery will decrease the risk of requiring a blood transfusion, as shown by a decreased incidence of blood transfusions, in the perioperative period.
Time frame: From surgery start time to discharge from hospital.
Resolution of anemia
As per the Government of British Columbia guidelines, the investigators will consider iron supplementation for blood Ferritin \< 20 mcg/L for participants aged 0 to 2 years old and \< 30 mcg/L for participants aged 3 years or older. Cases where Ferritin is \< 100 mcg/L, but Transferrin saturation is \<20% will also be considered for iron supplementation. Participants who fall into the above categories at the time of their initial nutrition consultation, but no longer do at the time of surgery, will have their anemia considered "resolved".
Time frame: From baseline to 12 months post-op.
Increased Iron Levels
Iron supplementation (if prescribed/necessary) will increase iron levels as proven by a comparison between the blood test at the time of the nutrition consultation and the time of surgery, as shown by Ferritin levels.
Time frame: From baseline to 12 months post-op.
Lower incidence of surgical site infection and pressure wounds
The investigators will compare the number and type of adverse outcomes (including surgical site infection and pressure wounds) between the retrospective (no intervention) and prospective (iron supplementation and/or nutrition management) groups.
Time frame: From the day of surgery to 30 days post-op.
Decreased hospital length of stay
Acute inpatient length of stay (days) between retrospective (no intervention) and prospective (iron supplementation and/or nutrition management) groups.
Time frame: From the date of surgery until the date of hospital discharge.
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — The investigators do not plan to share individual participant data for concern that patients may be identified.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of British Columbia