Effect of Prenatal Supplementation With Vitamin D on Asthma or Recurrent Wheezing in Offspring by Age 3 Years: The VDAART Randomized Clinical Trial.
Effect of Prenatal Supplementation With Vitamin D on Asthma or Recurrent Wheezing in Offspring by Age 3 Years: The VDAART Randomized Clinical Trial.
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DOI：
10.1001/jama.2015.18589
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发表时间：
2016-01-26
期刊：
影响因子：
--
通讯作者：
Weiss ST
中科院分区：
文献类型：
--
作者：
Litonjua AA;Carey VJ;Laranjo N;Harshfield BJ;McElrath TF;O'Connor GT;Sandel M;Iverson RE Jr;Lee-Paritz A;Strunk RC;Bacharier LB;Macones GA;Zeiger RS;Schatz M;Hollis BW;Hornsby E;Hawrylowicz C;Wu AC;Weiss ST
哮喘和喘息开始在生命的早期，和产前维生素D缺乏已被证实与这些疾病的后代。确定产前补充维生素D（胆钙化醇）是否可以预防儿童早期哮喘或反复喘息。维生素D减少哮喘试验是一项在美国3个中心进行的随机、双盲、安慰剂对照试验。入组于2009年10月开始，并于2015年1月完成随访。881名年龄在18 - 39岁之间的孕妇在怀孕10 - 18周时被随机分组，这些孕妇有高风险生育哮喘儿童。5名受试者在随机化后不久被认为不合格，并被中止。440名妇女随机接受每日4000 IU维生素D加含400 IU维生素D的产前维生素，436名妇女随机接受安慰剂加含400 IU维生素D的产前维生素。（1）父母报告3岁内医生诊断的哮喘或反复喘息和（2）孕晚期母亲25-羟基维生素D水平的共同主要结局。研究中有810名婴儿出生，806名婴儿被纳入3年结局分析。218名儿童发生哮喘或反复喘息：405人中有98人（24.3%; 95% CI，18.7%-28.5%），4400-IU组vs 120/401（30.4%，95% CI，25.7%-73.1%）（风险比，0.8; 95% CI，0.6-1.0; P = 0.051）。在4400-IU组的女性中，289人（74.9%）在妊娠晚期时25-羟基维生素D水平为30 ng/mL或更高，而400-IU组的391人中有133人（34.0%）（差异，40.9%; 95%CI，34.2%-47.5%，P <0.001）。在有哮喘风险的孕妇中，补充4400 IU/d的维生素D与400 IU/d相比，显着增加了妇女的维生素D水平。他们的孩子在3岁时哮喘和反复喘息的发生率降低了6.1%，但这并不符合统计学意义;然而，这项研究可能不够有力。对儿童的长期随访正在进行中，以确定这种差异是否具有临床意义。clinicaltrials.gov标识符：NCT 00920621
Asthma and wheezing begin early in life, and prenatal vitamin D deficiency has been variably associated with these disorders in offspring. To determine whether prenatal vitamin D (cholecalciferol) supplementation can prevent asthma or recurrent wheeze in early childhood. The Vitamin D Antenatal Asthma Reduction Trial was a randomized, double-blind, placebo-controlled trial conducted in 3 centers across the United States. Enrollment began in October 2009 and completed follow-up in January 2015. Eight hundred eighty-one pregnant women between the ages of 18 and 39 years at high risk of having children with asthma were randomized at 10 to 18 weeks’ gestation. Five participants were deemed ineligible shortly after randomization and were discontinued. Four hundred forty women were randomized to receive daily 4000 IU vitamin D plus a prenatal vitamin containing 400 IU vitamin D, and 436 women were randomized to receive a placebo plus a prenatal vitamin containing 400 IU vitamin D. Coprimary outcomes of (1) parental report of physician-diagnosed asthma or recurrent wheezing through 3 years of age and (2) third trimester maternal 25-hydroxyvitamin D levels. Eight hundred ten infants were born in the study, and 806 were included in the analyses for the 3-year outcomes. Two hundred eighteen children developed asthma or recurrent wheeze: 98 of 405 (24.3%; 95% CI, 18.7%–28.5%) in the 4400-IU group vs 120 of 401 (30.4%, 95% CI, 25.7%–73.1%) in the 400-IU group (hazard ratio, 0.8; 95% CI, 0.6–1.0; P = .051). Of the women in the 4400-IU group whose blood levels were checked, 289 (74.9%) had 25-hydroxyvitamin D levels of 30 ng/mL or higher by the third trimester of pregnancy compared with 133 of 391 (34.0%) in the 400-IU group (difference, 40.9%; 95% CI, 34.2%–47.5%, P < .001). In pregnant women at risk of having a child with asthma, supplementation with 4400 IU/d of vitamin D compared with 400 IU/d significantly increased vitamin D levels in the women. The incidence of asthma and recurrent wheezing in their children at age 3 years was lower by 6.1%, but this did not meet statistical significance; however, the study may have been underpowered. Longer follow-up of the children is ongoing to determine whether the difference is clinically important. clinicaltrials.gov Identifier: NCT00920621
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影响因子：
2.8
作者：
Ersfeld, DL;Rao, DS;MacFarlane, GD
通讯作者：
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