Table 1 World Health Organization Trial Registration Data Set – Structured Summary
Data category | Information |
|---|---|
Primary registry, trial identifying # | Clinicaltrials.gov Identifier - NCT01838447 |
Date of registration in primary registry | April 11, 2013 |
Secondary indentifying numbers | HICCUPS, VitaminDinCHD-01, 13/03E |
Sources of monetary support | Heart and Stroke Foundation of Canada Operating Grant, Children’s Hospital of Eastern Ontario Research Institute |
Primary sponsor | Heart and Stroke Foundation of Canada |
Secondary sponsor | Children’s Hospital of Eastern Ontario Research Institute |
Contact for public queries | JDM, Pediatric Critical Care, Children’s Hospital of Eastern Ontario, Ottawa, Canada |
Contact for scientific queries | JDM, Pediatric Critical Care, Children’s Hospital of Eastern Ontario, Ottawa, Canada |
Public title | Prevention of vitamin D deficiency after congenital heart disease surgery: a dose evaluation trial |
Scientific title | Prevention of vitamin D deficiency in children following cardiac surgery: a study protocol for a randomized dose evaluation trial |
Country of recruitment | Canada, single academic center |
Health problem under investigation | Prevention of vitamin D deficiency after congenital heart disease surgery |
Key inclusion and exclusion criteria | Ages eligible for study: Corrected gestational age >36 weeks and <18 years. |
Inclusion criteria: has CHD requiring surgical correction with cardiopulmonary bypass within 12 months | |
Exclusion criteria: born at <32 weeks gestational age; cardiac or gastrointestinal disease preventing enteral feeds or drug administration prior to surgery; has confirmed or suspected Williams syndrome; proposed surgery to take place at another center | |
Study type | Single center, double blind, parallel, randomized, controlled dose evaluation trial |
Date of first enrollment | June 2013 |
Target sample size | 62 |
Recruitment status | Recruiting as of June 2015 |
Primary outcome | Using immediate postoperative vitamin D status, (that is blood 25OHD) we will determine whether the preoperative administration vitamin D compared with usual care results in a significant reduction in postoperative vitamin D deficiency in a pediatric population with CHD. |
Key secondary outcomes | Vitamin D related adverse events (that is hypercalcemia, hypercalciuria); vitamin D axis functioning (active hormone, cardiac function); study feasibility |