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

Study acronym: VITALITY
StatusActive, Not Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Secondary endpoints: 28 to 23v15 See this version in full on ClinicalTrials.gov ↗
  2. Study Identification, Study Status, IPDSharingv14
  3. Re-verified, no change to tracked fieldsv13
  4. Primary completion date: Dec 2022 to Apr 2028 Primary endpoints: 1 to 2 · Trial status: Recruiting to Active, Not Recruiting · Enrollment target: estimated 3555 to confirmed 2739 · 6 morev12 Show 9 more changesShow less
    • Primary endpoints: 1 to 2
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 3555 to confirmed 2739
    • Completion date: Sep 2023 to Dec 2028
    • Secondary endpoints: 4 to 28
    • Study description expanded, about 323 words
    • Site details revised
    • Eligibility criteria expanded, about 4 words
    • Study title expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  5. Primary completion date: Jun 2022 to Dec 2022 Completion date: Dec 2022 to Sep 2023v11 Show 1 more changeShow less
    • Completion date: Dec 2022 to Sep 2023
Show 9 earlier versionsHide 9 earlier versions
  1. 2 versions Re-verified since May 28, 2019, no change to tracked fieldsv9-v10
  2. Primary completion date: Jan 2020 to Jun 2022 Primary endpoint revised · Enrollment target: 3012 to 3555 · Completion date: Dec 2020 to Dec 2022 · 2 morev8 Show 5 more changesShow less
    • Primary endpoint revised
    • Enrollment target: 3012 to 3555
    • Completion date: Dec 2020 to Dec 2022
    • Eligibility criteria expanded, about 169 words
    • Secondary endpoints: 1 to 4

    See this version in full on ClinicalTrials.gov ↗

  3. Re-verified, no change to tracked fieldsv7
  4. Enrollment target: 2330 to 3012v6
  5. Enrollment target: 3012 to 2330 Eligibility criteria revised · Publications: details revised at 1 of 3 entriesv5 Show 2 more changesShow less
    • Eligibility criteria revised
    • Publications: details revised at 1 of 3 entries

    See this version in full on ClinicalTrials.gov ↗

  6. Re-verified, no change to tracked fieldsv4
  7. Trial status: Not Yet Recruiting to Recruiting Start date: Jul 2014 to Dec 2014 · Site details revised · Publications: 2 to 3v3 Show 3 more changesShow less
    • Start date: Jul 2014 to Dec 2014
    • Site details revised
    • Publications: 2 to 3

    See this version in full on ClinicalTrials.gov ↗

  8. Interventions: Vitamin D (Drug) to Vitamin D (Drug), placebo (Drug) Eligibility criteria shortened, about 13 wordsv2 Show 1 more changeShow less
    • Eligibility criteria shortened, about 13 words

    See this version in full on ClinicalTrials.gov ↗

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT02112734
Lead Sponsor Murdoch Childrens Research Institute
Conditions Food Allergy
Enrollment 2,739 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov