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Trial record 82 of 108 for:    CALCIUM CATION

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
Sponsor:
Collaborators:
The Ottawa Hospital
McGill University
Children's University Hospital, Ireland
Ottawa Hospital Research Institute
Information provided by (Responsible Party):
James Dayre McNally, Children's Hospital of Eastern Ontario

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Vitamin D Deficiency
Thoracic Surgery
Pediatric Disorders
Heart Defects, Congenital
Intervention Dietary Supplement: Cholecalciferol
Enrollment 46
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Usual Care Group High Dose Group
Hide Arm/Group Description 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.

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.

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)

Period Title: Overall Study
Started 22 24
Completed 20 21
Not Completed 2 3
Reason Not Completed
Change in surgical plan             1             2
Withdrawal by Subject             1             1
Arm/Group Title Usual Care Group High Dose Group Total
Hide Arm/Group Description 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.

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.

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)

Total of all reporting groups
Overall Number of Baseline Participants 20 21 41
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Months
Number Analyzed 20 participants 21 participants 41 participants
3.8
(0.8 to 35.6)
4.6
(1.0 to 45.6)
4.3
(1.1 to 37.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 21 participants 41 participants
Female
7
  35.0%
11
  52.4%
18
  43.9%
Male
13
  65.0%
10
  47.6%
23
  56.1%
Weight (kg)  
Median (Inter-Quartile Range)
Unit of measure:  Kilograms
Number Analyzed 20 participants 21 participants 41 participants
5.8
(3.6 to 12.9)
5.4
(4.2 to 13.4)
5.7
(4.1 to 13.2)
RACHS Score   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Units on a scale
Number Analyzed 20 participants 21 participants 41 participants
3
(2 to 4)
2
(2 to 3)
3
(2 to 3)
[1]
Measure Description: The Risk Adjustment in Congenital Heart Surgery (RACHS) allows a detailed understanding of differences in mortality among pediatric patients who are undergoing surgery for congenital heart disease (CHD). Patients are assigned to to one of 6 risk categories (Risk Category 1 to Risk Category 6) based on the type of cardiac procedures. The risk categories group cardiac procedures with similar risks for in-hospital death together. A higher risk category means a higher risk of in-hospital death.
Other active medical condition  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 21 participants 41 participants
7
  35.0%
7
  33.3%
14
  34.1%
Surgery season  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 21 participants 41 participants
Winter
5
  25.0%
6
  28.6%
11
  26.8%
Spring
2
  10.0%
3
  14.3%
5
  12.2%
Summer
8
  40.0%
6
  28.6%
14
  34.1%
Fall
5
  25.0%
6
  28.6%
11
  26.8%
Ethnicity  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 21 participants 41 participants
Caucasian
14
  70.0%
14
  66.7%
28
  68.3%
Aboriginal
1
   5.0%
1
   4.8%
2
   4.9%
Oriental
3
  15.0%
0
   0.0%
3
   7.3%
African/West Indian
1
   5.0%
2
   9.5%
3
   7.3%
Unknown/Other
1
   5.0%
4
  19.0%
5
  12.2%
Expected Duration to Surgery at Time of Enrolment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 21 participants 41 participants
<2 months
18
  90.0%
18
  85.7%
36
  87.8%
>2 months
2
  10.0%
3
  14.3%
5
  12.2%
Type of Feeding in Children <1 year   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
Breast fed
9
  75.0%
10
  83.3%
19
  79.2%
Formula fed
3
  25.0%
2
  16.7%
5
  20.8%
[1]
Measure Analysis Population Description: Type of feeding is described for the sub-set of study participants who were <1 year of age at the time of randomization
1.Primary Outcome
Title Blood 25 Hydroxyvitamin D (25OHD) Concentrations
Hide Description 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.
Time Frame 1 day (On admission to the pediatric intensive care unit (PICU) following CHD surgery)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care Group High Dose Group
Hide Arm/Group Description:
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.

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.

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)

Overall Number of Participants Analyzed 19 20
Mean (Standard Deviation)
Unit of Measure: nmol/L
34.8  (12.0) 52.0  (23.3)
2.Secondary Outcome
Title Number of Participants With Hypercalcemia as a Vitamin D Related Adverse Event
Hide Description 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).
Time Frame Immediately before surgery, on admission to the PICU following CHD surgery, and on post-operative days 1,3,5 & 10
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care Group High Dose Group
Hide Arm/Group Description:
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.

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.

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)

Overall Number of Participants Analyzed 20 21
Measure Type: Number
Unit of Measure: No. participants with hypercalcemia
0 0
3.Secondary Outcome
Title Number of Participants With Hypercalciuria
Hide Description Hypercalciuria will be identified using calcium:creatinine ratios defined using age-specific norms and thresholds.
Time Frame Immediately before surgery, on admission to the PICU following CHD surgery, and on the first post-operative day
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Usual Care Group High Dose Group
Hide Arm/Group Description:
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.

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.

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)

Overall Number of Participants Analyzed 20 21
Measure Type: Count of Participants
Unit of Measure: Participants
Enrolment
1
   5.0%
0
   0.0%
Intra-operative
3
  15.0%
4
  19.0%
Post-Operative Day 1
2
  10.0%
1
   4.8%
4.Secondary Outcome
Title Vitamin D Parathyroid Renal Axis Function Through Changes in Blood 1,25-dihydroxycholecalciferol
Hide Description 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
Time Frame Immediately before surgery, on admission to the PICU following CHD surgery, and on post-operative days 1,3,5 & 10
Hide Outcome Measure Data
Hide Analysis Population Description
Data cannot be reported. Data was not collected.
Arm/Group Title Usual Care Group High Dose Group
Hide Arm/Group Description:
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.

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.

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)

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Changes in Cathelicidin as Measure of Innate Immune Function
Hide Description [Not Specified]
Time Frame Immediately before surgery, on admission to the PICU following CHD surgery, and on post-operative days 1,3,5 & 10
Hide Outcome Measure Data
Hide Analysis Population Description
This data cannot be reported. Data was not collected.
Arm/Group Title Usual Care Group High Dose Group
Hide Arm/Group Description:
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.

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.

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)

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Post-operative PICU Catecholamine Requirements
Hide Description 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)
Time Frame At any point between PICU admission and discharge, an average length of 5-7 days and not longer than 60 days
Hide Outcome Measure Data
Hide Analysis Population Description
Only the primary analysis (post-operative catecholamine requirements during the PICU admission will be evaluated as a dichotomous variable (yes/no)) was completed. Since there was not a significant difference between groups for this variable, we did not perform the secondary analysis (inotrope score).
Arm/Group Title Usual Care Group High Dose Group
Hide Arm/Group Description:
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.

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.

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)

Overall Number of Participants Analyzed 20 21
Measure Type: Count of Participants
Unit of Measure: Participants
15
  75.0%
11
  52.4%
7.Secondary Outcome
Title Cardiovascular Function Through an Echocardiogram
Hide Description The post-operative day 1 echocardiogram will be used to evaluate for differences in cardiovascular function between study arms.
Time Frame Post-operative day 1
Hide Outcome Measure Data
Hide Analysis Population Description
This data cannot be reported. Data was not collected.
Arm/Group Title Usual Care Group High Dose Group
Hide Arm/Group Description:
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.

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.

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)

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse event data was collected from the time of study enrollment until post-operative hospital discharge or 90 days following surgery for congenital heart disease (whichever occurred first)
Adverse Event Reporting Description Transient hypercalciuria without clinical symptoms was monitored but was not considered an adverse event. A priori, only persistent hypercalciuria with clinical symptoms was classified as an adverse event.
 
Arm/Group Title Usual Care Group High Dose Group
Hide Arm/Group Description 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.

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.

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)

All-Cause Mortality
Usual Care Group High Dose Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/21 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Usual Care Group High Dose Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/21 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Usual Care Group High Dose Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/21 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Katie O'Hearn, PICU Research Coordinator
Organization: Children's Hospital of Eastern Ontario
Phone: 613-737-7600 ext 4006
EMail: kohearn@cheo.on.ca
Publications:
Gallo S. et al. Supplementation with oral vitamin D3 (400 IU/day) supports plasma levels of 25-hydroxyvitamin D of 50nmol/L but higher intakes required to reach 75 nmol/L in breastfed infants. Canadian Paediatric Society Annual Conference, 2012.
Gallo S, Trussler K, Vanstone C, Rodd C, Weiler H. New ionized calcium values for newborn infants. American Society for Bone Research, 2008.
Cunniff C, Frias J, Kaye C, Moeschler J. Health care supervision for children with Williams syndrome. Pediatrics 107:1192-1204, 2001.
Village G. Health care supervision for children with Williams syndrome. Pediatrics, 2001.
Layout table for additonal information
Responsible Party: James Dayre McNally, Children's Hospital of Eastern Ontario
ClinicalTrials.gov Identifier: NCT01838447     History of Changes
Other Study ID Numbers: VITAMINDINCHD-01
First Submitted: April 11, 2013
First Posted: April 24, 2013
Results First Submitted: September 4, 2018
Results First Posted: July 22, 2019
Last Update Posted: July 22, 2019