title: 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.
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 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 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.
authors.affiliation: Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, MA, United States; Division of Pulmonary and Critical Care Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, MA, United States; Harvard Medical School, Boston, MA, United States. Electronic address: augusto.litonjua@channing.harvard.edu.
authors.forename: Augusto A
authors.initials: AA
authors.lastname: Litonjua
authors.affiliation: Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, MA, United States; Division of Pulmonary and Critical Care Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, MA, United States; Harvard Medical School, Boston, MA, United States.
authors.forename: Nancy E
authors.initials: NE
authors.lastname: Lange
authors.affiliation: Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, MA, United States; Harvard Medical School, Boston, MA, United States.
authors.forename: Vincent J
authors.initials: VJ
authors.lastname: Carey
authors.affiliation: Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, MA, United States.
authors.forename: Stacey
authors.initials: S
authors.lastname: Brown
authors.affiliation: Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, MA, United States.
authors.forename: Nancy
authors.initials: N
authors.lastname: Laranjo
authors.affiliation: Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, MA, United States.
authors.forename: Benjamin J
authors.initials: BJ
authors.lastname: Harshfield
authors.affiliation: Pulmonary Center, Department of Medicine, Boston University School of Medicine, Boston, MA, United States.
authors.forename: George T
authors.initials: GT
authors.lastname: O'Connor
authors.affiliation: Department of Pediatrics, Boston Medical Center, Boston, MA, United States.
authors.forename: Megan
authors.initials: M
authors.lastname: Sandel
authors.affiliation: Division of Pediatric Allergy, Immunology and Pulmonary Medicine, Department of Pediatrics, Washington University School of Medicine, St. Louis, MO, United States.
authors.forename: Robert C
authors.initials: RC
authors.lastname: Strunk
authors.affiliation: Division of Pediatric Allergy, Immunology and Pulmonary Medicine, Department of Pediatrics, Washington University School of Medicine, St. Louis, MO, United States.
authors.forename: Leonard B
authors.initials: LB
authors.lastname: Bacharier
authors.affiliation: Kaiser Permanente Southern California, San Diego, CA, United States.
authors.forename: Robert S
authors.initials: RS
authors.lastname: Zeiger
authors.affiliation: Kaiser Permanente Southern California, San Diego, CA, United States.
authors.forename: Michael
authors.initials: M
authors.lastname: Schatz
authors.affiliation: Department of Pediatrics, Medical University of South Carolina, Charleston, SC, United States.
authors.forename: Bruce W
authors.initials: BW
authors.lastname: Hollis
authors.affiliation: Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, MA, United States; Harvard Medical School, Boston, MA, United States.
authors.forename: Scott T
authors.initials: ST
authors.lastname: Weiss
mesh_terms: D001249:Asthma / Q000517:prevention & control*; D019587:Dietary Supplements; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006967:Hypersensitivity / Q000517:prevention & control*; D011247:Pregnancy; D011248:Pregnancy Complications / Q000517:prevention & control; D011295:Prenatal Care / Q000379:methods*; D011322:Primary Prevention / Q000379:methods; D012107:Research Design; D014807:Vitamin D / Q000008:administration & dosage*
chemical_list: D014807:Vitamin D
keywords: Allergy; Asthma; Developmental origins; Prenatal; Randomized controlled trial; Vitamin D