Child Health Division, Menzies School of Health Research, Charles Darwin University, Casuarina, Northern Territory, Australia
Child Health Division, Menzies School of Health Research, Charles Darwin University, Casuarina, Northern Territory, Australia.
BMJ Open Respir Res. 2023 Aug;10(1). doi: 10.1136/bmjresp-2023-001646.
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.
'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.
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.
ACTRN12618001174279.
在全球范围内，急性呼吸道感染（ARI）是导致儿童发病率和死亡率的主要原因。虽然在澳大利亚，ARI 相关死亡率较低，但与非原住民婴儿相比，原住民婴儿因 ARI 住院的次数多达 9 倍。北领地（NT）的差距最大，那里急性和慢性呼吸道感染的发病率是世界上报告最高的。维生素 D 缺乏症在 NT 原住民新生儿中很常见，并且与 ARI 住院风险增加有关。我们假设围产期维生素 D 补充剂将降低婴儿在生命的第一年患 ARI 的风险。
“D-Kids”是一项在 NT 原住民母婴对中进行的平行（1:1）、双盲（分配隐藏）、随机安慰剂对照试验。孕妇及其婴儿（n=314）接受维生素 D 或安慰剂。从 28 周到 34 周妊娠开始，孕妇每周接受 14000IU 或安慰剂，直到分娩，婴儿从出生到 4 个月大时每周接受 4200IU 或安慰剂。主要结局是在生命的第一年因 ARI 发作接受医疗关注的发生率。次要结局包括循环维生素 D 水平和鼻病原体流行率。三级结局包括婴儿免疫细胞表型和挑战反应。在四次研究访视中（入组、出生、婴儿 4 个月和 12 个月），采集血液、鼻腔拭子、母乳和唾液进行纵向采集。样本量提供了 90%的效力，以检测两组之间新 ARI 发作相对减少 27.5%。
该试验获得了 NT 人类研究伦理委员会的批准（2018-3160）。研究结果将通过书面和口头报告、教育研讨会、同行评议期刊、国家和国际会议，传播给参与者家庭、社区、当地决策者、更广泛的研究和临床社区。
ACTRN12618001174279。
