Prevention of vitamin D deficiency in children following cardiac surgery: study protocol for a randomized controlled trial

Abstract

BackgroundVitamin 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/DesignEligibility 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.DiscussionMaintaining 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 RegistrationClinicaltrials.gov Identifier - NCT01838447Date of registration: 11 April 2013Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-015-0922-8) contains supplementary material, which is available to authorized users.

Vitamin D Deficiency and Its Response to Supplementation as “Stoss Therapy” in Children with Cyanotic Congenital Heart Disease Undergoing Open Heart Surgery

“…6 The serum level of vitD decreases in these patients who undergo surgery with cardiopulmonary bypass (CPB). 7 Postoperatively these patients suffer significant morbidities, which may include a pronounced systemic inflammatory response (SIR), respiratory failure, electrolyte disturbances, arrhythmias, myocardial dysfunction, kidney failure, infections, and endocrine disturbances. [6][7][8][9][10] The role of vitD is recognized as a pleotropic hormone responsible for functioning of organ systems central to critical illness pathophysiology 11,12 including electrolyte homeostasis, cardiovascular health, inflammation, and innate immunity.…”

“…7 Postoperatively these patients suffer significant morbidities, which may include a pronounced systemic inflammatory response (SIR), respiratory failure, electrolyte disturbances, arrhythmias, myocardial dysfunction, kidney failure, infections, and endocrine disturbances. [6][7][8][9][10] The role of vitD is recognized as a pleotropic hormone responsible for functioning of organ systems central to critical illness pathophysiology 11,12 including electrolyte homeostasis, cardiovascular health, inflammation, and innate immunity. [13][14][15][16] Available data from many studies suggest that most CHD patients are vitD deficient following cardiac surgery and the immediate postoperative serum levels are associated with the subsequent clinical course.…”

Prevention of post-cardiac surgery vitamin D deficiency in children with congenital heart disease: a pilot feasibility dose evaluation randomized controlled trial

“…We conducted a single-center, double-blind, phase II dose evaluation pilot RCT from July 2013 to December 2015 at a Canadian tertiary center. The study rationale, design, and protocol have been previously published [ 32 ]. Ethical approval was obtained from the Children’s Hospital of Eastern Ontario Research Ethics Board (#13/03E), and regulatory approval was obtained from Health Canada (CTA #161404).…”

“…Given the expected 40% intraoperative decline in 25OHD concentrations due to the use of cardiopulmonary bypass, pre-operative 25OHD concentrations above 90 nmol/L are required to maintain post-operative 25OHD concentrations above 50 nmol/L. The HD dosing regimen was selected to achieve a pre-operative 25OHD target of 90 nmol/L [ 32 ]. Patients randomized to the usual care arm received the Adequate Intake doses for infants or recommended daily allowance for children > 1 year of age.…”

Аpplication of New Technologies for Identifying of Active Metabolites of Vitamin D (Review)

“…et.al. [22], підкреслює необхідність щоден-ного доопераційного доповнення вітаміну D у більших дозах, порівняно з тими, хто отримує звичайне споживання цього вітаміну.…”