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首页> 外文期刊>Contemporary clinical trials >The Vitamin D Antenatal Asthma Reduction Trial (VDAART): Rationale, design, and methods of a randomized, controlled trial of vitamin D supplementation in pregnancy for the primary prevention of asthma and allergies in children
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The Vitamin D Antenatal Asthma Reduction Trial (VDAART): Rationale, design, and methods of a randomized, controlled trial of vitamin D supplementation in pregnancy for the primary prevention of asthma and allergies in children

机译：维生素D减少产前哮喘试验（VDAART）：妊娠期补充维生素D以初步预防儿童哮喘和过敏的随机对照试验的原理，设计和方法

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There is intense interest in the role of vitamin D in the development of asthma and allergies. However, studies differ on whether a higher vitamin D intake or status in pregnancy or at birth is protective against asthma and allergies. To address this uncertainty, the Vitamin D Antenatal Asthma Reduction Trial (VDAART) was developed. VDAART is a randomized, double-blind, placebo-controlled trial of vitamin D supplementation in pregnant women to determine whether prenatal supplementation can prevent the development of asthma and allergies in women's offspring. A secondary aim is to determine whether vitamin D supplementation can prevent the development of pregnancy complications, such as preeclampsia, preterm birth, and gestational diabetes. Women were randomized to the treatment arm of 4000IU/day of vitamin D3 plus a daily multivitamin that contained 400IU of vitamin D3 or the placebo arm of placebo plus a multivitamin that contained 400IU daily of vitamin D3. Women who were between the gestational ages of 10 and 18weeks were randomized from three clinical centers across the United States - Boston Medical Center, Washington University in St. Louis, and Kaiser Permanente Southern California Region (San Diego, CA). Supplementation took place throughout pregnancy. Monthly monitoring of urinary calcium to creatinine ratio was performed in addition to medical record review for adverse events. Offspring are being evaluated quarterly through questionnaires and yearly during in-person visits until the 3rd birthday of the child. Ancillary studies will investigate neonatal T-regulatory cell function, maternal vaginal flora, and maternal and child intestinal flora.
机译：人们对维生素D在哮喘和过敏症发展中的作用非常感兴趣。但是，关于维生素D摄入量更高或妊娠或分娩状态对哮喘和过敏的保护作用存在差异。为了解决这种不确定性，开发了减少维生素D产前哮喘的试验（VDAART）。 VDAART是一项针对孕妇补充维生素D的随机，双盲，安慰剂对照试验，旨在确定产前补充维生素D是否可以预防女性后代的哮喘发作和过敏。第二个目的是确定补充维生素D是否可以防止妊娠并发症的发展，例如先兆子痫，早产和妊娠糖尿病。女性被随机分配到每天4000IU /天的维生素D3加每天包含400IU维生素D3的多种维生素的治疗组，或安慰剂的安慰剂臂再加上每天包含400IU维生素D3的多种维生素的治疗组。从美国三个临床中心（波士顿医学中心，圣路易斯华盛顿大学和南加州地区凯撒永久医学中心）随机分娩10至18周胎龄的妇女。在整个怀孕期间进行补充。除了检查不良事件的病历外，还每月监测尿钙与肌酐的比率。通过问卷调查对后代进行评估，并在面对面访问期间每年对后代进行评估，直到孩子三岁生日为止。辅助研究将调查新生儿T调节细胞功能，母体阴道菌群以及母婴肠道菌群。

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