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 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
Contemporary clinical trials · 157 citas
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Eventos clínicos como enfermedad o muerte
Quién lo pagó
- Financiación
- Financiación independiente
- Gobierno
- National Heart, Lung, and Blood Institute
- Gobierno
- NHLBI NIH HHS
- Sin clasificar
- VDAART
- Subvenciones
- National Heart, Lung, and Blood Institute (RO1 HL108818); National Heart, Lung, and Blood Institute (R01HL091528); National Heart, Lung, and Blood Institute (R01HL101390); National Heart, Lung, and Blood Institute (R01HL108818); National Heart, Lung, and Blood Institute (K12HL089990); National Heart, Lung, and Blood Institute (RO1 HL101390); National Heart, Lung, and Blood Institute (U01HL091528)
Según 3 financiadores declarados.
Publicación
- Publicado
- 2014-03-16 · Contemp Clin Trials · vol. 38 · número 1 · págs. 37–50
- Editorial
- Elsevier BV
- Citado
- 182 citas · más que el 99% de estudios similares · 10.7× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 108 trabajos
- Acceso
- Acceso abierto (copia en repositorio) · CC-BY
- Áreas de investigación
- Vitamin D Research Studies · Asthma and respiratory diseases · Birth, Development, and Health
- Palabras clave
- vitamin D supplementation, pregnancy, asthma prevention, pediatric allergy, prenatal nutrition, vitamin D3, preeclampsia, preterm birth, gestational diabetes mellitus, urinary calcium/creatinine ratio, regulatory T cells, vaginal microbiota, gut microbiota
- MeSH
- humans, asthma, pregnancy complications, hypersensitivity, vitamin d, prenatal care, double-blind method, primary prevention, pregnancy, research design, dietary supplements, female
14 autores
- Augusto A. Litonjua🇺🇸 · autor de correspondenciaBrigham and Women's Hospital; Harvard University
- Nancy E. Lange🇺🇸Brigham and Women's Hospital; Harvard University
- Vincent J. Carey🇺🇸Brigham and Women's Hospital; Harvard University
- Stacey Brown🇺🇸Brigham and Women's Hospital
- Nancy Laranjo🇺🇸Brigham and Women's Hospital
- Benjamin J. Harshfield🇺🇸Brigham and Women's Hospital
- George T. O’Connor🇺🇸Boston University
- Megan T. Sandel🇺🇸Boston Medical Center
- Robert C. Strunk🇺🇸Washington University in St. Louis
- Leonard B. Bacharier🇺🇸Washington University in St. Louis
- Robert S. Zeiger🇺🇸Kaiser Permanente
- Michael N. Schatz🇺🇸Kaiser Permanente
- Bruce W. Hollis🇺🇸Medical University of South Carolina
- Scott T. Weiss🇺🇸Brigham and Women's Hospital; Harvard University
Resumen
El texto original del estudio, en el idioma en que se publicó.
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.
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