Status:
COMPLETED
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
Lead Sponsor:
Children's Hospital of Eastern Ontario
Collaborating Sponsors:
The Ottawa Hospital
McGill University
Conditions:
Vitamin D Deficiency
Thoracic Surgery
Eligibility:
All Genders
Up to 17 years
Phase:
PHASE2
Brief 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 present...
Detailed Description
1 - INTRODUCTION 1.1 Summary of problem CHD is a common condition with an estimated prevalence of 1 per 100 in the general population. A significant proportion of these pediatric patients require one ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT01838447
Start Date
July 1 2013
End Date
December 1 2015
Last Update
July 22 2019
Active Locations (1)
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1
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada, K1H 8L1