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)
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|ClinicalTrials.gov Identifier: NCT01838447|
Recruitment Status : Completed
First Posted : April 24, 2013
Results First Posted : July 22, 2019
Last Update Posted : July 22, 2019
|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|
|Actual Primary Completion Date :||December 2015|
|Actual 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. A PICU admission blood sample could not be obtained for one patient in the Usual Care Group and one patient in the High Dose Group, thus the total number analyzed differs from the full sample size.
- Number of Participants With 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).
- Number of Participants With Hypercalciuria [ Time Frame: Immediately before surgery, on admission to the PICU following CHD surgery, and on the first post-operative day ]Hypercalciuria will be identified using calcium:creatinine 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). If a difference is noted in the primary analysis, inotrope requirements will be determined 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|