Vitamin D Deficiency Clinical Trial
— HICCUPS 2Official title:
Prevention of Post-Cardiac Surgery Vitamin D Deficiency in Children With Congenital Heart Disease: A Pilot Dose Evaluation Randomized Controlled Trial
Verified date | May 2019 |
Source | Children's Hospital of Eastern Ontario |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 46 |
Est. completion date | December 2015 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 17 Years |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
Canada | Children's Hospital of Eastern Ontario | Ottawa | Ontario |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital of Eastern Ontario | Children's University Hospital, Ireland, McGill University, Ottawa Hospital Research Institute, The Ottawa Hospital |
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* Note: There are 63 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Blood 25 Hydroxyvitamin D (25OHD) Concentrations | 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. | 1 day (On admission to the pediatric intensive care unit (PICU) following CHD surgery) | |
Secondary | Number of Participants With Hypercalcemia as a Vitamin D Related Adverse Event | 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). | Immediately before surgery, on admission to the PICU following CHD surgery, and on post-operative days 1,3,5 & 10 | |
Secondary | Number of Participants With Hypercalciuria | Hypercalciuria will be identified using calcium:creatinine ratios defined using age-specific norms and thresholds. | Immediately before surgery, on admission to the PICU following CHD surgery, and on the first post-operative day | |
Secondary | Vitamin D Parathyroid Renal Axis Function Through Changes in Blood 1,25-dihydroxycholecalciferol | 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 | Immediately before surgery, on admission to the PICU following CHD surgery, and on post-operative days 1,3,5 & 10 | |
Secondary | Changes in Cathelicidin as Measure of Innate Immune Function | Immediately before surgery, on admission to the PICU following CHD surgery, and on post-operative days 1,3,5 & 10 | ||
Secondary | Post-operative PICU Catecholamine Requirements | 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) | At any point between PICU admission and discharge, an average length of 5-7 days and not longer than 60 days | |
Secondary | Cardiovascular Function Through an Echocardiogram | The post-operative day 1 echocardiogram will be used to evaluate for differences in cardiovascular function between study arms. | Post-operative day 1 |
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