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.

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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DOI:
10.1016/j.cct.2014.02.006
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发表时间:
2014-05
影响因子:
2.2
通讯作者:
Weiss ST
Weiss ST
中科院分区:
医学4区
文献类型:
--
作者:
Litonjua AA;Lange NE;Carey VJ;Brown S;Laranjo N;Harshfield BJ;O'Connor GT;Sandel M;Strunk RC;Bacharier LB;Zeiger RS;Schatz M;Hollis BW;Weiss ST

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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。然而,关于怀孕或出生时较高的维生素D摄入量或状态是否可以预防哮喘和过敏,研究存在分歧。为了解决这种不确定性,开发了维生素D治疗哮喘减少试验(VDAART)。VDAART是一项在孕妇中补充维生素D的随机、双盲、安慰剂对照试验,以确定产前补充是否可以预防孕妇后代发生哮喘和过敏。第二个目的是确定维生素D补充剂是否可以预防妊娠并发症的发生,如先兆子痫,早产和妊娠糖尿病。妇女被随机分配到4,000 IU/天的维生素D3治疗组和每天含有400 IU维生素D3的多种维生素治疗组,或者安慰剂组和每天含有400 IU维生素D3的多种维生素治疗组。孕龄在10-18周之间的妇女从美国的三个临床中心--波士顿医学中心、圣路易斯的华盛顿大学和南加州地区的Kaiser Permanente(加利福尼亚州圣地亚哥)随机分组。整个怀孕期间都在补充。除了不良事件的病历审查外,还每月监测尿钙/肌酐比值。每季度通过问卷调查对后代进行评估,每年在亲自访问期间对后代进行评估,直到孩子3岁生日。辅助研究将调查新生儿T调节细胞功能、母体阴道植物群以及母体和儿童肠道植物群。
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 the 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 4,000 IU/day of vitamin D3 plus a daily multivitamin that contained 400 IU of vitamin D3 or the placebo arm of placebo plus a multivitamin that contained 400 IU daily of vitamin D3. Women who were between the gestational ages of 10–18 weeks 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.
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