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


Murdoch Childrens Research Institute
NCT ID: NCT02112734
Last Updated: November 26, 2017

The Study at a Glance

  • Status: Recruiting
  • Phase: Phase 4
  • Gender: All
  • Age: 6 Weeks - 8 Weeks
  • Condition: Food Allergy
  • Study Type: Interventional
  • Intervention:
  • Lead Sponsor: Murdoch Childrens Research Institute
  • Location: Not Provided

Official Title

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

Purpose

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 Vitamin D.

Eligibility

Ages Eligible for Study

6 Weeks to 8 Weeks

Sexes Eligible for Study

All

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

-Healthy, term, breastfeeding infants who will be predominately breastfed for at least
6-months. This will be determined by answering yes/no to question ‘do you intend to
breastfeed until your infant is at least 6 months of age.’

Exclusion Criteria:

– Infants who have already received postnatal vitamin D supplementation

– prematurity (<37 weeks)/low birthweight <2500 g - poor health due to a current or past significant disease state or congenital abnormality.

Additional Information, Locations & Contacts

Sponsors & Collaborators

Murdoch Childrens Research Institute

Investigators

Principal Investigator: Katie Allen, PhD

On-X Life Technologies, Inc.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02112734

Location

Contacts

Murdoch Childrens Research Institute

Melbourne, Victoria 3052

Australia