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
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 wi...
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ftpubmed:oai:pubmedcentral.nih.gov:10432658 2023-09-05T13:19:27+02:00 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 Binks, Michael J Bleakley, Amy S Pizzutto, Susan J Lamberth, Michelle Powell, Verity Nelson, Jane Kirby, Adrienne Morris, Peter S Simon, David Mulholland, E Kim Rathnayake, Geetha Leach, Amanda J D'Antoine, Heather Licciardi, Paul V Snelling, Tom Chang, Anne B 2023-08-16 http://www.ncbi.nlm.nih.gov/pmc/articles/PMC10432658/ http://www.ncbi.nlm.nih.gov/pubmed/37586777 https://doi.org/10.1136/bmjresp-2023-001646 en eng BMJ Publishing Group http://www.ncbi.nlm.nih.gov/pmc/articles/PMC10432658/ http://www.ncbi.nlm.nih.gov/pubmed/37586777 http://dx.doi.org/10.1136/bmjresp-2023-001646 © Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ. 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/. BMJ Open Respir Res Respiratory Infection Text 2023 ftpubmed https://doi.org/10.1136/bmjresp-2023-001646 2023-08-20T01:10:27Z 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. Text First Nations PubMed Central (PMC) Ari ENVELOPE(147.813,147.813,59.810,59.810) Aris ENVELOPE(-61.400,-61.400,-70.633,-70.633) BMJ Open Respiratory Research 10 1 e001646 |
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PubMed Central (PMC) |
op_collection_id |
ftpubmed |
language |
English |
topic |
Respiratory Infection |
spellingShingle |
Respiratory Infection Binks, Michael J Bleakley, Amy S Pizzutto, Susan J Lamberth, Michelle Powell, Verity Nelson, Jane Kirby, Adrienne Morris, Peter S Simon, David Mulholland, E Kim Rathnayake, Geetha Leach, Amanda J D'Antoine, Heather Licciardi, Paul V Snelling, Tom Chang, Anne B 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 |
topic_facet |
Respiratory Infection |
description |
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. |
format |
Text |
author |
Binks, Michael J Bleakley, Amy S Pizzutto, Susan J Lamberth, Michelle Powell, Verity Nelson, Jane Kirby, Adrienne Morris, Peter S Simon, David Mulholland, E Kim Rathnayake, Geetha Leach, Amanda J D'Antoine, Heather Licciardi, Paul V Snelling, Tom Chang, Anne B |
author_facet |
Binks, Michael J Bleakley, Amy S Pizzutto, Susan J Lamberth, Michelle Powell, Verity Nelson, Jane Kirby, Adrienne Morris, Peter S Simon, David Mulholland, E Kim Rathnayake, Geetha Leach, Amanda J D'Antoine, Heather Licciardi, Paul V Snelling, Tom Chang, Anne B |
author_sort |
Binks, Michael J |
title |
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 |
title_short |
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 |
title_full |
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 |
title_fullStr |
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 |
title_full_unstemmed |
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 |
title_sort |
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 |
publisher |
BMJ Publishing Group |
publishDate |
2023 |
url |
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC10432658/ http://www.ncbi.nlm.nih.gov/pubmed/37586777 https://doi.org/10.1136/bmjresp-2023-001646 |
long_lat |
ENVELOPE(147.813,147.813,59.810,59.810) ENVELOPE(-61.400,-61.400,-70.633,-70.633) |
geographic |
Ari Aris |
geographic_facet |
Ari Aris |
genre |
First Nations |
genre_facet |
First Nations |
op_source |
BMJ Open Respir Res |
op_relation |
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC10432658/ http://www.ncbi.nlm.nih.gov/pubmed/37586777 http://dx.doi.org/10.1136/bmjresp-2023-001646 |
op_rights |
© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ. 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/. |
op_doi |
https://doi.org/10.1136/bmjresp-2023-001646 |
container_title |
BMJ Open Respiratory Research |
container_volume |
10 |
container_issue |
1 |
container_start_page |
e001646 |
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1776200226007154688 |