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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02112734
Recruitment Status : Recruiting
First Posted : April 14, 2014
Last Update Posted : November 28, 2017
Information provided by (Responsible Party):
Katrina Allen, Murdoch Childrens Research Institute

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 Vitamin D.

Condition or disease Intervention/treatment Phase
Food Allergy Drug: Vitamin D Drug: placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3012 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Can Vitamin D Supplementation in Infants Prevent Food Allergy in the First Year of Life? The VITALITY Trial.
Study Start Date : December 2014
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

Arm Intervention/treatment
Active Comparator: vitamin D
400 IU /daily cholecalciferol/vitamin D
Drug: Vitamin D
400 IU/daily for 10 months
Other Name: cholecalciferol

Placebo Comparator: placebo
carrier formulation minus vitamin D
Drug: placebo
identical placebo daily
Other Name: placebo is identical carrier minus vitamin D

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

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

Other Outcome Measures:
  1. doctor diagnosed eczema during the first postnatal year [ Time Frame: age 12 months ]
  2. vitamin D insufficiency [ Time Frame: at age 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Weeks to 8 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02112734

Contact: Michael Field 613 99366027

Australia, Victoria
Murdoch Childrens Research Institute Recruiting
Melbourne, Victoria, Australia, 3052
Sponsors and Collaborators
Murdoch Childrens Research Institute
Principal Investigator: Katie Allen, PhD On-X Life Technologies, Inc.

Responsible Party: Katrina Allen, Prof Katrina Allen, Murdoch Childrens Research Institute Identifier: NCT02112734     History of Changes
Other Study ID Numbers: HREC # 34168 A
First Posted: April 14, 2014    Key Record Dates
Last Update Posted: November 28, 2017
Last Verified: November 2017

Keywords provided by Katrina Allen, Murdoch Childrens Research Institute:
vitamin D
food allergy

Additional relevant MeSH terms:
Food Hypersensitivity
Immune System Diseases
Hypersensitivity, Immediate
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents