DO IT Trial: Vitamin D Outcomes and Interventions in Toddlers - a TARGet Kids! randomized controlled trial

Jonathon L. Maguire, Catherine S. Birken, Mark B. Loeb, Muhammad Mamdani, Kevin Thorpe, Jeffrey S Hoch, Tony Mazzulli, Cornelia M. Borkhoff, Colin Macarthur, Patricia C. Parkin, Kawsari Abdullah, Laura Anderson, Sarah Carsley, Yang Chen, Matthew D'Ascanio, Mikael Katz-Lavigne, Kanthi Kavikondala, Grace Jieun Lee, Jessica Omand, Navindra PersaudMeta van den Heuvel, Weeda Zabih, Jillian Baker, Tony Barozzino, Joey Bonifacio, Douglas Campbell, Sohail Cheema, Brian Chisamore, Karoon Danayan, Paul Das, Mary Beth Derocher, Anh Do, Michael Dorey, Sloane Freeman, Keewai Fung, Charlie Guiang, Curtis Handford, Hailey Hatch, Sheila Jacobson, Tara Kiran, Holly Knowles, Bruce Kwok, Sheila Lakhoo, Margarita Lam-Antoniades, Eddy Lau, Fok Han Leung, Jennifer Loo, Sarah Mahmoud, Rosemary Moodie, Julia Morinis, Sharon Naymark, Patricia Neelands, James Owen, Michael Peer, Marty Perlmutar, Andrew Pinto, Michelle Porepa, Nasreen Ramji, Noor Ramji, Alana Rosenthal, Janet Saunderson, Rahul Saxena, Michael Sgro, Susan Shepherd, Barbara Smiltnieks, Carolyn Taylor, Thea Weisdors, Sheila Wijayasinghe, Peter Wong, Ethel Ying, Elizabeth Young

Research output: Contribution to journalArticle

12 Scopus citations

Abstract

Background: Vitamin D levels are alarmingly low (<75 nmol/L) in 65-70% of North American children older than 1 year. An increased risk of viral upper respiratory tract infections (URTI), asthma-related hospitalizations and use of anti-inflammatory medication have all been linked with low vitamin D. No study has determined whether wintertime vitamin D supplementation can reduce the risk of URTI and asthma exacerbations, two of the most common and costly illnesses of early childhood. The objectives of this study are: 1) to compare the effect of 'high dose' (2000 IU/day) vs. 'standard dose' (400 IU/day) vitamin D supplementation in achieving reductions in laboratory confirmed URTI and asthma exacerbations during the winter in preschool-aged Canadian children; and 2) to assess the effect of 'high dose' vitamin D supplementation on vitamin D serum levels and specific viruses that cause URTI.Methods/Design: This study is a pragmatic randomized controlled trial. Over 4 successive winters we will recruit 750 healthy children 1-5 years of age. Participating physicians are part of a primary healthcare research network called TARGet Kids!. Children will be randomized to the 'standard dose' or 'high dose' oral supplemental vitamin D for a minimum of 4 months (200 children per group). Parents will obtain a nasal swab from their child with each URTI, report the number of asthma exacerbations and complete symptom checklists. Unscheduled physician visits for URTIs and asthma exacerbations will be recorded. By May, a blood sample will be drawn to determine vitamin D serum levels. The primary analysis will be a comparison of URTI rate between study groups using a Poisson regression model. Secondary analyses will compare vitamin D serum levels, asthma exacerbations and the frequency of specific viral agents between groups.Discussion: Identifying whether vitamin D supplementation of preschoolers can reduce wintertime viral URTIs and asthma exacerbations and what dose is optimal may reduce population wide morbidity and associated health care and societal costs. This information will assist in determining practice and health policy recommendations related to vitamin D supplementation in healthy Canadian preschoolers.

Original languageEnglish (US)
Article number37
JournalBMC Pediatrics
Volume14
Issue number1
DOIs
StatePublished - Feb 8 2014
Externally publishedYes

Keywords

  • Infant
  • Toddler
  • Vitamin D deficiency
  • Vitamin D supplementation

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health

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    Maguire, J. L., Birken, C. S., Loeb, M. B., Mamdani, M., Thorpe, K., Hoch, J. S., Mazzulli, T., Borkhoff, C. M., Macarthur, C., Parkin, P. C., Abdullah, K., Anderson, L., Carsley, S., Chen, Y., D'Ascanio, M., Katz-Lavigne, M., Kavikondala, K., Lee, G. J., Omand, J., ... Young, E. (2014). DO IT Trial: Vitamin D Outcomes and Interventions in Toddlers - a TARGet Kids! randomized controlled trial. BMC Pediatrics, 14(1), [37]. https://doi.org/10.1186/1471-2431-14-37