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Phase 2 N=46 Randomized Quadruple-blind Prevention

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

Vitamin D Deficiency · Thoracic Surgery · Pediatric Disorders · Heart Defects, Congenital

Enrolled (actual)
46
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcome: Primary: Blood 25 Hydroxyvitamin D (25OHD) Concentrations — 34.8; 52.0 nmol/L

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Cholecalciferol (Dietary_supplement)
Age
Pediatric
Sex
All
Sponsor
Children's Hospital of Eastern Ontario
Primary completion
Dec 2015

Outcome Measures

OutcomeResultp-value
PRIMARY
Blood 25 Hydroxyvitamin D (25OHD) Concentrations
34.8; 52.0
SECONDARY
Number of Participants With Hypercalcemia as a Vitamin D Related Adverse Event
0; 0
SECONDARY
Number of Participants With Hypercalciuria
1; 0; 3; 4; 2; 1
SECONDARY
Vitamin D Parathyroid Renal Axis Function Through Changes in Blood 1,25-dihydroxycholecalciferol
SECONDARY
Changes in Cathelicidin as Measure of Innate Immune Function
SECONDARY
Post-operative PICU Catecholamine Requirements
15; 11
SECONDARY
Cardiovascular Function Through an Echocardiogram

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)
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01838447). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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