Can Vitamin D Supplementation in the First Year of Life Prevent Food Allergy in Infants? The VITALITY Trial: Parts 1&2

NCT02112734 | Active Not Recruiting Phase 4 DMC

• 1 other identifier: HREC # 34168 A
• Study Type: interventional
• Target: 2,739
• Locations: 1 country
• Sites: 1

Brief Summary

We report that Australia has the highest prevalence of Immunoglobulin(Ig)E-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). 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 and other allergic disease at 12 months (part 1) and 6 years of age (part 2). 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.

Conditions

Food Allergy

Keywords

vitamin D; food allergy; eczema

Outcome Measures

Primary Outcomes (2)

• The prevalence of challenge-proven food allergy at 12 months of age

  The prevalence of challenge-proven food allergy at 12 months of age determined by a positive SPT and a positive oral food challenge

  At 12 months of age

• The occurrence of definite food allergy or tolerance at 6 years of age

  The occurrence of definite food allergy or tolerance at 6 years of age can only be determined by combining data from an oral food challenge, a skin prick test (SPT) and/or serum specific IgE test, and/or parent/self-reported ingestion history and reactions to the index food.

  At 6 years of age

Secondary Outcomes (23)

• The prevalence of food sensitisation at 12 months of age determined by SPT positive

  At 12 months of age

• The prevalence of doctor diagnosed eczema during the first postnatal year

  During the first postnatal year

• 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

  At 12 months of age

• Allergy-related healthcare utilisation within the first 12 months of life

  Within the first 12 months of life

• Infection episodes within the first 12 months of life

  Within the first 12 months of life

Study Arms (2)

vitamin D

ACTIVE COMPARATOR

400 IU /daily cholecalciferol/vitamin D

Drug: Vitamin D

placebo

PLACEBO COMPARATOR

carrier formulation minus vitamin D

Drug: placebo

Interventions

Vitamin D DRUG

400 IU/daily until age 12 months

Also known as: cholecalciferol

vitamin D

placebo DRUG

identical placebo daily

Also known as: placebo is identical carrier minus vitamin D

placebo

Eligibility Criteria

• Age: 6 Weeks - 12 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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/Small for gestational age (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.

Sponsors & Collaborators

• Murdoch Childrens Research Institute: lead

Study Sites (1)

Murdoch Childrens Research Institute

Melbourne, Victoria, 3052, Australia

Location

Related Publications (3)

• Allen KJ, Koplin JJ, Ponsonby AL, Gurrin LC, Wake M, Vuillermin P, Martin P, Matheson M, Lowe A, Robinson M, Tey D, Osborne NJ, Dang T, Tina Tan HT, Thiele L, Anderson D, Czech H, Sanjeevan J, Zurzolo G, Dwyer T, Tang ML, Hill D, Dharmage SC. Vitamin D insufficiency is associated with challenge-proven food allergy in infants. J Allergy Clin Immunol. 2013 Apr;131(4):1109-16, 1116.e1-6. doi: 10.1016/j.jaci.2013.01.017. Epub 2013 Feb 27.

  PMID: 23453797 BACKGROUND

• Allen KJ, Panjari M, Koplin JJ, Ponsonby AL, Vuillermin P, Gurrin LC, Greaves R, Carvalho N, Dalziel K, Tang ML, Lee KJ, Wake M, Curtis N, Dharmage SC. VITALITY trial: protocol for a randomised controlled trial to establish the role of postnatal vitamin D supplementation in infant immune health. BMJ Open. 2015 Dec 16;5(12):e009377. doi: 10.1136/bmjopen-2015-009377.

  PMID: 26674499 BACKGROUND

• Shen Z, Robert L, Stolpman M, Che Y, Allen KJ, Saffery R, Walsh A, Young A, Eckert J, Deming C, Chen Q, Conlan S, Laky K, Li JM, Chatman L, Kashaf SS; NISC Comparative Sequencing Program; VITALITY team; Kong HH, Frischmeyer-Guerrerio PA, Perrett KP, Segre JA. A genome catalog of the early-life human skin microbiome. Genome Biol. 2023 Nov 10;24(1):252. doi: 10.1186/s13059-023-03090-w.

  PMID: 37946302 DERIVED

MeSH Terms

Conditions

Food Hypersensitivity; Eczema

Interventions

Vitamin D; Cholecalciferol

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cholestenes; Cholestanes; Sterols; Membrane Lipids; Lipids

Study Officials

• Kirsten Perrett, MD PhD

  Murdoch Childrens Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2014
• First Posted: April 14, 2014
• Study Start: December 1, 2014
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: December 3, 2025

Record last verified: 2025-11

Locations

AU (1)