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 wid...
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crjcrbmj:10.1136/bmjresp-2023-001646 2024-09-15T18:06:28+00:00 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 NHMRC 2023 http://dx.doi.org/10.1136/bmjresp-2023-001646 https://syndication.highwire.org/content/doi/10.1136/bmjresp-2023-001646 en eng BMJ https://creativecommons.org/licenses/by/4.0/ BMJ Open Respiratory Research volume 10, issue 1, page e001646 ISSN 2052-4439 journal-article 2023 crjcrbmj https://doi.org/10.1136/bmjresp-2023-001646 2024-08-29T04:10:30Z 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. Article in Journal/Newspaper First Nations The BMJ BMJ Open Respiratory Research 10 1 e001646 |
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English |
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. |
author2 |
NHMRC |
format |
Article in Journal/Newspaper |
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 |
spellingShingle |
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 |
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 |
publishDate |
2023 |
url |
http://dx.doi.org/10.1136/bmjresp-2023-001646 https://syndication.highwire.org/content/doi/10.1136/bmjresp-2023-001646 |
genre |
First Nations |
genre_facet |
First Nations |
op_source |
BMJ Open Respiratory Research volume 10, issue 1, page e001646 ISSN 2052-4439 |
op_rights |
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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1810443896386224128 |