Prevention of vitamin D deficiency in children following cardiac surgery: study protocol for a randomized controlled
J Dayre McNally1,2, Katie O'Hearn3, Margaret L Lawson4,5
1Department of Pediatrics, Faculty of Medicine, University of Ottawa, Children's Hospital of Eastern Ontario, Ottawa, Canada. dayre.mcnally@gmail.com.
Insights
This study investigated high-dose vitamin D supplementation in children undergoing heart surgery. Preoperative supplementation may prevent vitamin D deficiency and aid recovery in pediatric cardiac patients.
Area of Science:
- Pediatric Cardiology
- Endocrinology
- Nutritional Science
Background:
- Vitamin D deficiency is prevalent in children post-cardiac surgery.
- Low vitamin D levels correlate with poorer outcomes.
- Preoperative supplementation may improve recovery.
Purpose of the Study:
- To compare immediate postoperative vitamin D status in children receiving high-dose versus usual-intake vitamin D supplementation.
- To assess the efficacy of preoperative vitamin D supplementation in preventing deficiency after congenital heart disease surgery.
Main Methods:
- A randomized controlled trial (RCT) involving 62 children (age >36 weeks to <18 years) undergoing cardiopulmonary bypass for congenital heart defects.
- Two arms: high-dose preoperative vitamin D supplementation (based on Institute of Medicine tolerable upper intake levels) and a low-dose (usual care) arm.
- Primary outcome: immediate postoperative serum 25(OH)D levels.
Main Results:
- Data on main results are not available in the provided abstract.
Conclusions:
- Adequate postoperative vitamin D levels may enhance recovery after congenital heart disease surgery.
- Preoperative supplementation based on tolerable upper intake levels could prevent deficiency in most children.
- Results will inform larger international RCTs on vitamin D optimization for improved outcomes.
Background:
Vitamin D is a pleiotropic hormone important for the recovery of organ systems after critical illness. Recent observational studies have suggested that three out of every four children are vitamin D deficient following cardiac surgery, with inadequate preoperative intake and surgical losses playing important contributory roles. Observed associations between postoperative levels, cardiovascular dysfunction and clinical course suggest that perioperative optimization of vitamin D status could improve outcome. With this two-arm, parallel, double blind, randomized controlled trial (RCT), we aim to compare immediate postoperative vitamin D status in children requiring cardiopulmonary bypass for congenital heart disease who receive preoperative daily high dose vitamin D supplementation (high-dose arm) with those who receive usual intake (low-dose arm).
Methods/Design:
Eligibility requirements include age (>36 weeks, <18 years) and a congenital heart defect requiring cardiopulmonary bypass surgical correction. Enrollment of 62 participants will take place at a single Canadian tertiary care center over a period of 2 years. Children randomized to the high-dose group will receive age-based dosing that was informed by the Institute of Medicine (IOM) daily tolerable upper intake level (<1 year old = 1,600 IU/day, >1 year old = 2,400 IU/day). Children in the low-dose arm will receive usual care based on IOM recommendations (<1 year old = 400 IU, >1 year old = 600 IU). The primary outcome measure is immediate postoperative vitamin D status, using blood 25(OH)D.
Discussion:
Maintaining adequate postoperative vitamin D levels following surgery could represent an effective therapy to speed recovery following CHD surgery. The proposed research project will determine whether preoperative supplementation with a dosing regimen based on the IOM recommended daily upper tolerable intake will prevent postoperative vitamin-D deficiency in the majority of children. The results will then be used to inform the design of a large international RCT exploring whether preoperative optimization of vitamin D status might improve short and long-term outcomes in this vulnerable population.
Trial Registration:
Clinicaltrials.gov Identifier--NCT01838447 Date of registration: 11 April 2013.
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