Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
ClinicalTrials.gov Identifier: NCT02112734
Recruitment Status : Recruiting
First Posted : April 14, 2014
Last Update Posted : May 21, 2019
Sponsor:
Information provided by (Responsible Party):
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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3555 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 : June 2022
Estimated Study Completion Date : December 2022

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 until age 12 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 of challenge-proven food allergy at 12 months of age determined by both positive SPT and positive oral food challenge [ Time Frame: At 12 months of age ]
    The prevalence of challenge-proven food allergy at 12 months of age determined by both positive SPT and positive oral food challenge


Secondary Outcome Measures :
  1. The prevalence of food sensitisation at 12 months of age determined by SPT positive [ Time Frame: At 12 months of age ]
    The prevalence of food sensitisation at 12 months of age determined by SPT positive

  2. The prevalence of doctor diagnosed eczema during the first postnatal year [ Time Frame: During the first postnatal year ]
    The prevalence of doctor diagnosed eczema during the first postnatal year

  3. The prevalence of vitamin D insufficiency (serum concentration of 25(OH)D <50 nmol/L ) at age 12 months determined by measuring blood taken at the 12 month clinic visit [ Time Frame: At 12 months of age ]
    The prevalence of vitamin D insufficiency (serum concentration of 25(OH)D <50 nmol/L ) at age 12 months determined by measuring blood taken at the 12 month clinic visit

  4. Allergy-related healthcare utilisation within the first 12 months of life [ Time Frame: Within the first 12 months of life ]
    Allergy-related healthcare utilisation within the first 12 months of life



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Weeks to 12 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Each participant must meet the following criteria to be included in this study:

  • Healthy, term (born no earlier than 2 weeks before estimated date of delivery), predominantly breastfeeding infants aged 6 to 12 weeks (inclusive) who are expected to be predominantly breastfed for at least 6-months. This will be determined by answering yes/no to question 'do you intend/wish to breastfeed until your infant is at least 6 months of age.' Up to one bottle (approx. 120mL) of formula per 24 hours at the time of screening is acceptable, as this will contain <100 IU vitamin D.
  • Has a parent/legally acceptable representative (LAR) capable of understanding the informed consent document and providing consent on the subject's behalf,
  • The parent must expect to be able to complete 4 online questionnaires over the infant's first 12 months of life and for the infant to be available for skin prick testing (+/- food challenge) at The Royal Children's Hospital at 12 months of age.

Exclusion Criteria:

Participants meeting any of the following criteria will be excluded from the study:

  • Infants who are currently receiving vitamin D supplementation
  • Infants on medication that interferes with vitamin D metabolism
  • Poor health due to a current or past significant disease state or congenital abnormality.
  • Prematurity <37 weeks/low birth weight <2500 g/SGA
  • Unable to provide consent without the aid of an interpreter.
  • Women at high risk of vitamin D deficiency with infants on vitamin D supplementation.

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 ClinicalTrials.gov identifier (NCT number): NCT02112734


Contacts
Layout table for location contacts
Contact: Michael Field 613 99366027 vitality@mcri.edu.au
Contact: Jennifer Koplin jennifer.koplin@mcri.edu.au

Locations
Layout table for location information
Australia, Victoria
Murdoch Childrens Research Institute Recruiting
Melbourne, Victoria, Australia, 3052
Sponsors and Collaborators
Murdoch Childrens Research Institute
Investigators
Layout table for investigator information
Principal Investigator: Kirsten Perrett, MD PhD On-X Life Technologies, Inc.

Publications:
Layout table for additonal information
Responsible Party: Murdoch Childrens Research Institute
ClinicalTrials.gov Identifier: NCT02112734     History of Changes
Other Study ID Numbers: HREC # 34168 A
First Posted: April 14, 2014    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: March 2019

Keywords provided by Murdoch Childrens Research Institute:
vitamin D
food allergy
eczema

Additional relevant MeSH terms:
Layout table for MeSH terms
Hypersensitivity
Food Hypersensitivity
Immune System Diseases
Hypersensitivity, Immediate
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents