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 (HICCUPS 2)
|ClinicalTrials.gov Identifier: NCT01838447|
Recruitment Status : Completed
First Posted : April 24, 2013
Last Update Posted : January 28, 2016
|Condition or disease||Intervention/treatment||Phase|
|Vitamin D Deficiency Thoracic Surgery Pediatric Disorders Heart Defects, Congenital||Dietary Supplement: Cholecalciferol||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||46 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Prevention of Post-Cardiac Surgery Vitamin D Deficiency in Children With Congenital Heart Disease: A Pilot Dose Evaluation Randomized Controlled Trial|
|Study Start Date :||July 2013|
|Primary Completion Date :||December 2015|
|Study Completion Date :||December 2015|
No Intervention: Usual care group
This group will receive daily cholecalciferol (vitamin D3) based on the Adequate Intake (AI) for infants and the Recommended Dietary Allowance (RDA) for children over 1 year. Specific dose amounts are 400 IU per day for infants (0-1 year), and 600 IU per day for children between 1-17 years. Infants under 12 months of age who are formula fed will be given a placebo solution.
Experimental: High Dose Group
This group will receive cholecalciferol (vitamin D3) based on the age-specific tolerable daily upper intake level (UL). Specific dose amounts are 1600 IU per day for infants (0-1 year), and 2400 IU per day for children between 1-17 years. Infants under 12 months of age who are formula fed will be given a dose of 1200 IU per day to account for vitamin D in formula.
Dietary Supplement: Cholecalciferol
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)
Other Name: Vitamin D3
- Blood 25 hydroxyvitamin D (25OHD) concentrations [ Time Frame: 1 day (On admission to the pediatric intensive care unit (PICU) following CHD surgery) ]Blood 25OHD will be measured to determine vitamin D deficiency, with a concentration below 50 nmol/L used to define deficiency.
- Hypercalcemia as a Vitamin D related adverse event [ Time Frame: Immediately before surgery, on admission to the PICU following CHD surgery, and on post-operative days 1,3,5 & 10 ]Hypercalcemia will be defined as an ionized calcium level above 1.40 mmol/L; or above 1.45 mmol/L for children under 8 weeks. Hypercalcemia will be evaluated in blood collected immediately before CHD surgery and throughout the post-operative course (measurements are standard of care).
- Hypercalcuria as a vitamin D related adverse event [ Time Frame: Immediately before surgery, on admission to the PICU following CHD surgery, and on the first post-operative day ]Hypercalcuria will be identified using calcium:creatine ratios defined using age-specific norms and thresholds
- Vitamin D parathyroid renal axis function through changes in blood 1,25-dihydroxycholecalciferol [ Time Frame: Immediately before surgery, on admission to the PICU following CHD surgery, and on post-operative days 1,3,5 & 10 ]Impaired vitamin D axis function will be defined as an inability to restore and maintain active hormone levels in the normal range following surgery after the first post-operative day
- Changes in cathelicidin as measure of innate immune function [ Time Frame: Immediately before surgery, on admission to the PICU following CHD surgery, and on post-operative days 1,3,5 & 10 ]
- Post-operative PICU catecholamine requirements [ Time Frame: At any point between PICU admission and discharge, an average length of 5-7 days and not longer than 60 days ]Primarily, post-operative catecholamine requirements during the PICU admission will be evaluated as a dichotomous variable (yes/no). Secondarily, inotrope requirements will be determine using the inotrope score, evaluated as the maximum score and in a time to event approach (off all inotropes, score of zero)
- Cardiovascular function through an echocardiogram [ Time Frame: Post-operative day 1 ]The post-operative day 1 echocardiogram will be used to evaluate for differences in cardiovascular function between study arms.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01838447
|Children's Hospital of Eastern Ontario|
|Ottawa, Ontario, Canada, K1H 8L1|
|Principal Investigator:||James D McNally, M.D., Ph.D.||Children's Hospital of Eastern Ontario|
|Study Chair:||Kusum Menon, M.D.||Children's Hospital of Eastern Ontario|
|Study Chair:||Lauralyn McIntyre, M.D.||Ottawa Hospital|
|Study Chair:||Dermot R Doherty, M.B., B.Ch.||Temple Street Children's University Hospital Dublin and University College|
|Study Chair:||Dean Ferguson, Ph.D.||Ottawa Hospital Research Institute|
|Study Chair:||Hope Weiler, Ph.D.||McGill University|