Evidence map›Paper›PMID 26674499›Full record

Trial reportBMJ open2015

VITALITY trial: protocol for a randomised controlled trial to establish the role of postnatal vitamin D supplementation in infant immune health.

Katrina J Allen, Mary Panjari, Jennifer J Koplin, Anne-Louise Ponsonby, Peter Vuillermin, Lyle C Gurrin, Ronda Greaves, Natalie Carvalho, Kim Dalziel, Mimi L K Tang and 4 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMJ open, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02112734 (Can Vitamin D Supplementation Prevent Food Allergy in Infants? The VITALITY Trial), which is not on this map. Cited by 23 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 3 pooled it
3.5field-weighted citation impact, top 7% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02112734 phase4active not recruitingnot on this map

Can Vitamin D Supplementation Prevent Food Allergy in Infants? The VITALITY Trial

TypeinterventionalSponsorMurdoch Childrens Research InstituteRan2014 to 2028Enrolled2,739ConditionsFood AllergyArmsVitamin D, placebo
3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 3 syntheses or guidelines pooled it, 60 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Article
  5. Article
  6. Review
  7. Review
  8. Environmental Interventions for Preventing Atopic Diseases.Current allergy and asthma reports · 2024
    Review
  9. Article
  10. A genome catalog of the early-life human skin microbiome.bioRxiv : the preprint server for biology · 2023
    Article
  11. Review
  12. Article
  13. Review
  14. Article
  15. An Overview of Environmental Risk Factors for Food Allergy.International journal of environmental research and public health · 2022
    Review
  16. Review
  17. Real-World LEAP Implementation.Current allergy and asthma reports · 2021
    Review
  18. Allergy Prevention: An Overview of Current Evidence.The Yale journal of biology and medicine · 2020
    Review
  19. Review
  20. Factors Affecting Vitamin D Status in Infants.Children (Basel, Switzerland) · 2019
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors at 3 institutions in 1 country.

Katrina J AllenThe Murdoch Childrens Research Institute, Parkville, Victoria, Australia The Department of Paediatrics, University of Melbourne, Parkville, Victoria, Australia The Department of Allergy and Immunology, Royal Children's Hospital, Parkville, Victoria, Australia.
Mary PanjariThe Murdoch Childrens Research Institute, Parkville, Victoria, Australia.
Jennifer J KoplinThe Murdoch Childrens Research Institute, Parkville, Victoria, Australia The Department of Paediatrics, University of Melbourne, Parkville, Victoria, Australia.
Anne-Louise PonsonbyThe Murdoch Childrens Research Institute, Parkville, Victoria, Australia The Department of Paediatrics, University of Melbourne, Parkville, Victoria, Australia.
Peter VuillerminThe Murdoch Childrens Research Institute, Parkville, Victoria, Australia.
Lyle C GurrinThe Murdoch Childrens Research Institute, Parkville, Victoria, Australia The Centre for Epidemiology and Biostatistics, University of Melbourne, Parkville, Victoria, Australia.
Ronda GreavesThe Murdoch Childrens Research Institute, Parkville, Victoria, Australia School of Medical Sciences, RMIT University, Bundoora, Victoria, Australia.
Natalie CarvalhoCentre for Health Policy, Melbourne School of Population and Global Health, The University of Melbourne, Melbourne, Melbourne, Australia.
Kim DalzielCentre for Health Policy, Melbourne School of Population and Global Health, The University of Melbourne, Melbourne, Melbourne, Australia.
Mimi L K TangThe Murdoch Childrens Research Institute, Parkville, Victoria, Australia The Department of Paediatrics, University of Melbourne, Parkville, Victoria, Australia.
Katherine J LeeThe Murdoch Childrens Research Institute, Parkville, Victoria, Australia The Department of Paediatrics, University of Melbourne, Parkville, Victoria, Australia The Melbourne Children's Trials Centre (MCRI), Melbourne, Victoria, Australia.
Melissa WakeThe Murdoch Childrens Research Institute, Parkville, Victoria, Australia The Department of Paediatrics, University of Melbourne, Parkville, Victoria, Australia.
Nigel CurtisThe Murdoch Childrens Research Institute, Parkville, Victoria, Australia The Department of Paediatrics, University of Melbourne, Parkville, Victoria, Australia.
Shyamali C DharmageThe Murdoch Childrens Research Institute, Parkville, Victoria, Australia The Department of Allergy and Immunology, Royal Children's Hospital, Parkville, Victoria, Australia.
Murdoch Children's Research Institute · AUUniversity of Melbourne · AURoyal Children's Hospital · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPostnatal vitamin D supplementation may be associated with a reduction in IgE-mediated food allergy, lower respiratory tract infections and improved bone health. Countries in the Northern hemisphere recommend universal infant vitamin D supplementation to optimise early vitamin D levels, despite the absence of large trials proving safety or efficacy for any disease outcome. With the aim of determining the clinical and cost-effectiveness of daily vitamin D supplementation in breastfed infants from age 6-8 weeks to 12 months of age, we have started a double-blind, randomised, placebo-controlled trial of daily 400 IU vitamin D supplementation during the first year of life, VITALITY. METHODS ND ANALYSIS: Infants (n=3012) who are fully breastfed and not receiving vitamin D supplementation will be recruited at the time of their first immunisation, from council-led immunisation clinics throughout metropolitan Melbourne, Australia. The primary outcome is challenge-proven food allergy at 12 months of age. Secondary outcomes are food sensitisation (positive skin prick test), number of lower respiratory infections (through hospital linkage), moderately-severe and persistent eczema (by history and examination) and vitamin D deficiency (serum vitamin D <50 nmol/L) at age 12 months. The trial is underway and the first 130 participants have been recruited. ETHICS AND DISSEMINATION: The VITALITY study is approved by the Royal Children's Hospital (RCH) Human Research Ethics Committee (#34168). Outcomes will be disseminated through publication and will be presented at scientific conferences. TRIAL REGISTRATION NUMBERS: ANZCTR12614000334606 and NCT02112734; pre-results.

Indexed as

Breast FeedingDietary SupplementsClinical ProtocolsDouble-Blind MethodEczemaFood HypersensitivityHumansInfantResearch DesignRespiratory Tract InfectionsVitamin DVitamin D DeficiencyVitaminsVitamin DVitaminsEPIDEMIOLOGYPAEDIATRICSPREVENTIVE MEDICINE

Identifiers

PMID26674499
PMCPMC4691762
OpenAlexW2214462493

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.