哮喘联盟

维生素D出生前干预哮喘试验(VDAART)：孕期补充维生素D对儿童哮喘和过敏初级预防作用的随机对照试验的基本原理、设计和方法
 

   摘要
   目前已非常重视维生素D在哮喘和过敏发展中的作用。然而，在孕期或出生时较高剂量维生素D摄入量或水平是否可预防哮喘和过敏的研究各不相同。为了解决这一困扰，开展了维生素D出生前干预哮喘试验(VDAART)。VDAART是一项有关孕产妇补充维生素D的随机，双盲，安慰剂对照试验，旨在明确产前补充维生素D是否可预防后代哮喘和过敏的发展；其次是为了确定维生素D补充是否可预防妊娠并发症的发展，如先兆子痫、早产和妊娠期糖尿病。孕妇被随机分为两组，治疗组每日给予维生素D3 4000IU/d加含维生素D3 400IU的多种维生素剂；安慰剂组每日给予安慰剂加含维生素D3 400IU的多种维生素剂。从美国的三个临床中心（波士顿医疗中心，华盛顿大学圣路易斯分校以及南加州地区）随机选择胎龄在10-18 周的孕妇。整个孕期补充维生素。除了病历所记录的不良事件外，对其尿钙和肌酸酐的比值进行每月监测。每季度以及每年通过问卷调查的方式对子代进行评估，直到儿童3周岁。附属的研究将评估新生儿调节性T细胞功能、母亲的阴道菌群、以及母亲和儿童的肠道菌群。
 

（苏楠 审校）
ContempClinTrials.2014Mar7.pii:S1551-7144(14)00026-3.doi:10.1016/j.cct.2014.02.006. [Epub ahead of print]

 

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.
 

Litonjua AA1, Lange NE2, Carey VJ3, Brown S4, Laranjo N4, O'Connor GT5, Sandel M6, Strunk RC7, Bacharier LB7, Zeiger RS8, Schatz M8, Hollis BW9, Weiss ST3.
 

Abstract
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 4,000IU/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 10-18weeks 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.
 

ContempClinTrials.2014Mar7.pii:S1551-7144(14)00026-3.doi:10.1016/j.cct.2014.02.006. [Epub ahead of print]