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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Online Access: | https://doi.org/10.1136/bmjresp-2023-001646 https://doaj.org/article/a3e779d152874d75b61d2bd1397259a4 |
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ftdoajarticles:oai:doaj.org/article:a3e779d152874d75b61d2bd1397259a4 2024-02-04T10:00:25+01:00 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 Anne B Chang Peter S Morris Tom Snelling Paul V Licciardi Michael J Binks David Simon E Kim Mulholland Adrienne Kirby Heather D'Antoine Amy S Bleakley Susan J Pizzutto Michelle Lamberth Verity Powell Jane Nelson Geetha Rathnayake Amanda J Leach 2023-11-01T00:00:00Z https://doi.org/10.1136/bmjresp-2023-001646 https://doaj.org/article/a3e779d152874d75b61d2bd1397259a4 EN eng BMJ Publishing Group https://bmjopenrespres.bmj.com/content/10/1/e001646.full https://doaj.org/toc/2052-4439 doi:10.1136/bmjresp-2023-001646 2052-4439 https://doaj.org/article/a3e779d152874d75b61d2bd1397259a4 BMJ Open Respiratory Research, Vol 10, Iss 1 (2023) Medicine R Diseases of the respiratory system RC705-779 article 2023 ftdoajarticles https://doi.org/10.1136/bmjresp-2023-001646 2024-01-07T01:46:21Z 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 Directory of Open Access Journals: DOAJ Articles 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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Open Polar |
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Directory of Open Access Journals: DOAJ Articles |
op_collection_id |
ftdoajarticles |
language |
English |
topic |
Medicine R Diseases of the respiratory system RC705-779 |
spellingShingle |
Medicine R Diseases of the respiratory system RC705-779 Anne B Chang Peter S Morris Tom Snelling Paul V Licciardi Michael J Binks David Simon E Kim Mulholland Adrienne Kirby Heather D'Antoine Amy S Bleakley Susan J Pizzutto Michelle Lamberth Verity Powell Jane Nelson Geetha Rathnayake Amanda J Leach 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 |
Medicine R Diseases of the respiratory system RC705-779 |
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 |
Article in Journal/Newspaper |
author |
Anne B Chang Peter S Morris Tom Snelling Paul V Licciardi Michael J Binks David Simon E Kim Mulholland Adrienne Kirby Heather D'Antoine Amy S Bleakley Susan J Pizzutto Michelle Lamberth Verity Powell Jane Nelson Geetha Rathnayake Amanda J Leach |
author_facet |
Anne B Chang Peter S Morris Tom Snelling Paul V Licciardi Michael J Binks David Simon E Kim Mulholland Adrienne Kirby Heather D'Antoine Amy S Bleakley Susan J Pizzutto Michelle Lamberth Verity Powell Jane Nelson Geetha Rathnayake Amanda J Leach |
author_sort |
Anne B Chang |
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 |
https://doi.org/10.1136/bmjresp-2023-001646 https://doaj.org/article/a3e779d152874d75b61d2bd1397259a4 |
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 Respiratory Research, Vol 10, Iss 1 (2023) |
op_relation |
https://bmjopenrespres.bmj.com/content/10/1/e001646.full https://doaj.org/toc/2052-4439 doi:10.1136/bmjresp-2023-001646 2052-4439 https://doaj.org/article/a3e779d152874d75b61d2bd1397259a4 |
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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1789965684614103040 |