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  • Randomised controlled trial of perinatal vitamin D supplementation to prevent early-onset acute respiratory infections among Australian First Nations children: the ‘D-Kids’ study protocol

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Respiratory infection
Randomised controlled trial of perinatal vitamin D supplementation to prevent early-onset acute respiratory infections among Australian First Nations children: the ‘D-Kids’ study protocol
  1. Michael J Binks1,
  2. Amy S Bleakley1,
  3. Susan J Pizzutto1,
  4. Michelle Lamberth1,2,
  5. Verity Powell1,2,
  6. Jane Nelson1,
  7. Adrienne Kirby3,
  8. Peter S Morris1,4,
  9. David Simon2,
  10. E Kim Mulholland5,6,
  11. Geetha Rathnayake7,
  12. Amanda J Leach1,
  13. Heather D'Antoine1,
  14. Paul V Licciardi5,8,
  15. Tom Snelling9,10 and
  16. Anne B Chang1,11
  1. 1Child Health Division, Menzies School of Health Research, Charles Darwin University, Casuarina, Northern Territory, Australia
  2. 2Department of Obstetrics and Gynaecology, Royal Darwin Hospital, Tiwi, Northern Territory, Australia
  3. 3National Health and Medical Research Council Clinical Trials Centre, University of Sydney CAR, Glebe, New South Wales, Australia
  4. 4Department of Paediatrics, Royal Darwin Hospital, Tiwi, Northern Territory, Australia
  5. 5New Vaccines Research Group, Murdoch Children's Research Institute, Parkville, Victoria, Australia
  6. 6Epidemiology and Public Health, London School of Hygiene & Tropical Medicine, London, UK
  7. 7Virtus Diagnostics, Sydney, New South Wales, Australia
  8. 8Department of Paediatrics, University of Melbourne VCCC, Parkville, Victoria, Australia
  9. 9School of Public Health, The University of Sydney, Sydney, New South Wales, Australia
  10. 10Wesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute, Nedlands, Western Australia, Australia
  11. 11Centre for Children's Health Research, Queensland University of Technology, Brisbane, Queensland, Australia
  1. Correspondence to Dr Michael J Binks; Michael.Binks{at}menzies.edu.au

Abstract

Introduction Globally, acute respiratory infections (ARIs) are a leading cause of childhood morbidity and mortality. While ARI-related mortality is low in Australia, First Nations infants are hospitalised with ARIs up to nine times more often than their non-First Nations counterparts. The gap is widest in the Northern Territory (NT) where rates of both acute and chronic respiratory infection are among the highest reported in the world. Vitamin D deficiency is common among NT First Nations neonates and associated with an increased risk of ARI hospitalisation. We hypothesise that perinatal vitamin D supplementation will reduce the risk of ARI in the first year of life.

Methods and analysis ‘D-Kids’ is a parallel (1:1), double-blind (allocation concealed), randomised placebo-controlled trial conducted among NT First Nations mother–infant pairs. Pregnant women and their babies (n=314) receive either vitamin D or placebo. Women receive 14 000 IU/week or placebo from 28 to 34 weeks gestation until birth and babies receive 4200 IU/week or placebo from birth until age 4 months. The primary outcome is the incidence of ARI episodes receiving medical attention in the first year of life. Secondary outcomes include circulating vitamin D level and nasal pathogen prevalence. Tertiary outcomes include infant immune cell phenotypes and challenge responses. Blood, nasal swabs, breast milk and saliva are collected longitudinally across four study visits: enrolment, birth, infant age 4 and 12 months. The sample size provides 90% power to detect a 27.5% relative reduction in new ARI episodes between groups.

Ethics and dissemination This trial is approved by the NT Human Research Ethics Committee (2018-3160). Study outcomes will be disseminated to participant families, communities, local policy-makers, the broader research and clinical community via written and oral reports, education workshops, peer-reviewed journals, national and international conferences.

Trial registration number ACTRN12618001174279.

  • Respiratory Infection
  • Bacterial Infection
  • Viral infection
  • Pneumonia
  • Infection Control
  • Innate Immunity

Data availability statement

No data are available. This is a protocol paper, and therefore, there are no associated data.

https://creativecommons.org/licenses/by/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

https://doi.org/10.1136/bmjresp-2023-001646

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    Data availability statement

    No data are available. This is a protocol paper, and therefore, there are no associated data.

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    Footnotes

    • Contributors MJB designed and wrote the trial protocol and analysis plan. SJP, AK, PSM, HD'A, TS and ABC contributed to the design and analysis plan. VP, ML and JN guided the protocol logistics and GCP compliance. MJB and ASB drafted the manuscript. All named authors contributed to subsequent drafts and approved the final manuscript.

    • Funding The trial was funded by a 5-year NHMRC of Australia project grant (1138604).

    • Competing interests None declared.

    • Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.