产前维生素 D 减少哮喘发作的试验 6 年随访结果。
Six-Year Follow-up of a Trial of Antenatal Vitamin D for Asthma Reduction.
机构信息
From the Division of Pulmonary Medicine, Department of Pediatrics, Golisano Children's Hospital at Strong, University of Rochester Medical Center, Rochester, NY (A.A.L.); the Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital (V.J.C., N.L., B.J.S., H.M., S.T.W.), Harvard Medical School (V.J.C., H.M., S.T.W.), the Pulmonary Center, Department of Medicine, Boston University School of Medicine (G.T.O.), and the Department of Pediatrics, Boston Medical Center (M. Sandel) - all in Boston; the Division of Allergy, Immunology, and Pulmonary Medicine, Department of Pediatrics, St. Louis Children's Hospital, Washington University School of Medicine, St. Louis (A.B., L.B.B.); Kaiser Permanente Southern California, San Diego (R.S.Z., M. Schatz); and the Department of Pediatrics, Medical University of South Carolina, Charleston (B.W.H.).
出版信息
N Engl J Med. 2020 Feb 6;382(6):525-533. doi: 10.1056/NEJMoa1906137.
BACKGROUND
We previously reported the results of a trial of prenatal vitamin D supplementation to prevent asthma and recurrent wheeze in young children, which suggested that supplementation provided a protective effect at the age of 3 years. We followed the children through the age of 6 years to determine the course of asthma and recurrent wheeze.
METHODS
In this follow-up study, investigators and participants remained unaware of the treatment assignments through the children's sixth birthday. We aimed to determine whether, when maternal levels of 25-hydroxyvitamin D were taken into account, children born to mothers who had received 4400 IU of vitamin D per day during pregnancy (vitamin D group) would have a lower incidence of asthma and recurrent wheeze at the age of 6 years than would those born to mothers who had received 400 IU of vitamin D per day (control group). Time-to-event methods were used to compare the treatment groups with respect to time to the onset of asthma or recurrent wheeze. Multivariate methods were used to compare longitudinal measures of lung function between the treatment groups.
RESULTS
There was no effect of maternal vitamin D supplementation on asthma and recurrent wheeze in either an intention-to-treat analysis or an analysis with stratification according to the maternal 25-hydroxyvitamin D level during pregnancy. There was no effect of prenatal vitamin D supplementation on most of the prespecified secondary outcomes. We found no effects of prenatal supplementation on spirometric indexes. Although there was a very small effect on airway resistance as measured by impulse oscillometry, this finding was of uncertain significance.
CONCLUSIONS
Vitamin D supplementation during the prenatal period alone did not influence the 6-year incidence of asthma and recurrent wheeze among children who were at risk for asthma. (Funded by the National Heart, Lung, and Blood Institute; VDAART ClinicalTrials.gov number, NCT00920621.).
背景
我们曾报道过一项关于产前补充维生素 D 以预防幼儿哮喘和反复喘息的试验结果，该试验表明补充维生素 D 在 3 岁时具有保护作用。我们对这些儿童进行了随访，直到他们 6 岁，以确定哮喘和反复喘息的病程。
方法
在这项随访研究中，研究人员和参与者在儿童 6 岁生日前对治疗分配保持不知情。我们旨在确定在考虑到母体 25-羟维生素 D 水平的情况下，与每天接受 400IU 维生素 D 治疗的母亲所生的儿童相比，每天接受 4400IU 维生素 D 治疗的母亲所生的儿童在 6 岁时哮喘和反复喘息的发生率是否更低。采用时间事件方法比较治疗组之间哮喘或反复喘息的发病时间。采用多变量方法比较治疗组之间肺功能的纵向测量值。
结果
无论在意向治疗分析还是根据母体妊娠期间 25-羟维生素 D 水平分层的分析中，母体维生素 D 补充都没有影响哮喘和反复喘息的发生。产前维生素 D 补充对大多数预先指定的次要结局没有影响。我们没有发现产前补充对肺功能指标有影响。虽然通过脉冲振荡测量法发现气道阻力有很小的影响，但这一发现意义不大。
结论
单独在孕期补充维生素 D 并不能影响有哮喘风险的儿童 6 岁时哮喘和反复喘息的发生率。（由美国国立心肺血液研究所资助；VDAART 临床试验.gov 编号，NCT009 20621。）
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