Clinical Trial: Can Vitamin D Supplementation in Infants Prevent Food Allergy in the First Year of Life? The VITALITY Trial

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Can Vitamin D Supplementation in Infants Prevent Food Allergy in the First Year of Life? The VITALITY Trial.

Brief Summary: There is an urgent need to prevent the onset and progression of food allergy in our population. Evidence demonstrates that food allergy and atopic eczema represent the earliest manifestations of the atopic march with 50% of infants with food allergy predicted to develop respiratory allergic diseases later in life. We report that Australia has the highest prevalence of IgE-mediated food allergy in the world, with 10% of infants having challenge-proven food allergy in Melbourne. There has been a 5-fold increase in hospital admissions for life-threatening anaphylaxis. These changes are most pronounced in children less than 5 years, suggesting a causal role for early life determinants. We have primary data to inform hypotheses for the rise in food allergy, which appears to result from potentially modifiable factors related to the modern lifestyle, particularly Vitamin D insufficiency (VDI), and have demonstrated an association between VDI and increased risk of challenge-proven food allergy in 12-month old infants, which supports numerous ecological studies showing an increased risk of food allergy the further a child resides from the equator (associated with decreased UV exposure and Vitamin D levels). Despite Australia's sunny climate, population rates of VDI have steadily increased in infants and pregnant women in parallel to the apparent rise in food allergic disease. This association is biologically plausible, as there is evidence Vitamin D is critical to the healthy development of the immune system in early life. We propose an intervention study to assess if infant Vitamin D supplementation during the first year of life significantly decreases the risk of early-onset food allergy. Australia is ideally placed to answer this important question since, unlike the USA, Canada and Europe, there are no population recommendations for routine infant supplementation with Vitamin D and we are one of the few developed countries that do not supplement the food chain supply with

Detailed Summary:
Sponsor: Murdoch Childrens Research Institute

Current Primary Outcome: the prevalence and severity of challenge-proven food allergy in study participants with positive skin prick tests (SPT) [ Time Frame: at age 12 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome: prevalence of food sensitisation (positive skin prick) test [ Time Frame: age 12 months ]

Original Secondary Outcome: Same as current

Information By: Murdoch Childrens Research Institute

Dates:
Date Received: April 10, 2014
Date Started: December 2014
Date Completion: December 2020
Last Updated: August 12, 2016
Last Verified: August 2016