Prevention of Vitamin D Deficiency Following Pediatric CHD Surgery: a Phase II Dose Evaluation Randomized Controlled Trial Comparing Usual Care With a High Dose Pre-operative Supplementation Regimen Based on the Institute of Medicine Daily Upper Tolerable Intake Level
Condition: Vitamin D Deficiency; Thoracic Surgery; Pediatric Disorders; Heart Defects, Congenital
MeSH terms: Heart Defects, Congenital; Congenital Abnormalities; Vitamin D Deficiency
Intervention: Cholecalciferol
Intervention description: The High Dose group is based on the age-specific UL. These doses were chosen to elevate 25OHD well above 50 nmol/L, while minimizing the risk of vitamin D toxicity (e.g. hypercalcemia, hypercalciuria)
Intervention MeSH terms: Vitamin D; Cholecalciferol
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 46.0
Sex: All
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Vitamin D; Congenital Heart Disease; Cardiac Surgery; Pediatrics; Phase II Clinical Trial

Summary:

      Our research group has shown that almost all children with congenital heart disease (CHD) are
      vitamin D deficient following heart surgery. This work strongly suggests that the vitamin D
      intake presently recommended for healthy children, and also given to children with CHD, is
      inadequate to prevent vitamin D deficiency following surgery. Unfortunately, there have been
      no studies investigating any other vitamin D dose in children with heart disease. Recently, a
      higher dose of vitamin D intake has been approved (by the Institute of Medicine and Health
      Canada) and recent work on healthy children has shown it to be safe. The objective of this
      study is to determine whether this recently approved higher dose of vitamin D can safely
      reduce the number of children who are vitamin D deficient following surgery. This dose
      evaluation study will also evaluate whether it is possible to perform a large study (across
      Canada) to determine whether vitamin D supplementation can improve outcomes following
      surgery. It is hypothesized that a daily high dose vitamin D regimen, modeled on the
      Institute of Medicine daily upper tolerable intake level (UL), will significantly reduce
      vitamin D deficiency following CHD surgery, when compared with usual intake.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Newborn (corrected gestational age between 36 weeks) up to 18 years

          -  Has CHD that will require surgery within the next 12 months

          -  CHD requiring surgical intervention with cardiopulmonary bypass

        Exclusion Criteria:

          -  Born at less than 32 weeks gestational age

          -  Corrected gestational age of less than 36 weeks

          -  Cardiac or gastrointestinal disease preventing enteral feeds or drug administration
             prior to surgery

          -  Patient has confirmed or suspected Williams syndrome

          -  Proposed surgery to take place at another centre (outside of CHEO)