Financiado en parte por GlaxoSmithKline, Teva Pharmaceutical Industries
Effect of Prenatal Supplementation With Vitamin D on Asthma or Recurrent Wheezing in Offspring by Age 3 Years: The VDAART Randomized Clinical Trial
Litonjua AA, Carey VJ, Laranjo N, Harshfield BJ, McElrath TF, O'Connor GT, Sandel M, Iverson RE, Lee-Paritz A, Strunk RC, Bacharier LB, Macones GA, Zeiger RS, Schatz M, Hollis BW, Hornsby E, Hawrylowicz C, Wu AC, Weiss ST
JAMA · 337 citas
Etiquetas de revisión
Financiado por la industriaDatos neutrales que nuestra revisión registró sobre cómo se hizo este estudio. Describen el método, nunca si nos gusta el resultado.
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
- Financiado por la industria
- Empresa
- GlaxoSmithKline
- Empresa
- Teva Pharmaceutical Industries
- Organización sin fines de lucro
- Wellcome Trust
- Organización sin fines de lucro
- Asthma and Lung UK
- Gobierno
- National Institutes of Health
- Gobierno
- Medical Research Council
- Gobierno
- National Heart, Lung, and Blood Institute
- Gobierno
- National Center for Advancing Translational Sciences
- Gobierno
- NCATS NIH HHS
- Gobierno
- NHLBI NIH HHS
- Subvenciones
- Wellcome Trust (G100758); National Heart, Lung, and Blood Institute (U01 HL091528); National Center for Advancing Translational Sciences (U54TR001012); National Institutes of Health (U54 TR001012); National Institutes of Health (U01HL091528)
Según 10 financiadores declarados.
Publicación
- Publicado
- 2016-01-26 · JAMA · vol. 315 · número 4 · pág. 362
- Editorial
- American Medical Association
- Citado
- 440 citas · más que el 100% de estudios similares · 47.4× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 34 trabajos
- Acceso
- Lectura gratuita
- Áreas de investigación
- Vitamin D Research Studies · Asthma and respiratory diseases · Neonatal Respiratory Health Research
- Palabras clave
- Medicine, Offspring, Asthma, Pediatrics, Vitamin, Vitamin D and neurology, Pregnancy, Internal medicine, Genetics
- MeSH
- fetal blood, humans, asthma, vitamin d deficiency, recurrence, respiratory sounds, cholecalciferol, vitamins, vitamin d, double-blind method, pregnancy, pregnancy trimester, third, dietary supplements, adult, child, preschool, female, male, young adult
19 autores
- Augusto A. Litonjua🇺🇸 · autor de correspondenciaBrigham and Women's Hospital; Harvard University
- Vincent J. Carey🇺🇸Brigham and Women's Hospital; Harvard University
- Nancy Laranjo🇺🇸Brigham and Women's Hospital
- Benjamin J. Harshfield🇺🇸Brigham and Women's Hospital
- Thomas Frederick McElrath🇺🇸Brigham and Women's Hospital; Harvard University
- George T. O’Connor🇺🇸Boston University
- Megan T. Sandel🇺🇸Boston Medical Center
- Ronald E. Iverson🇺🇸Boston Medical Center
- Aviva Lee-Paritz🇺🇸Boston Medical Center
- Robert C. Strunk🇺🇸St. Louis Children's Hospital
- Leonard B. Bacharier🇺🇸St. Louis Children's Hospital
- George A. Macones🇺🇸Washington University in St. Louis
- Robert S. Zeiger🇺🇸Kaiser Permanente
- Michael X. Schatz🇺🇸Kaiser Permanente
- Bruce W. Hollis🇺🇸Medical University of South Carolina
- Eve Hornsby🇬🇧Guy's Hospital; King's College London
- Catherine M. Hawrylowicz🇬🇧Guy's Hospital; King's College London
- Ann Chen Wu🇺🇸Harvard University; Harvard Pilgrim Health Care
- Scott T. Weiss🇺🇸Brigham and Women's Hospital; Harvard University
Resumen
El texto original del estudio, en el idioma en que se publicó.
Importance
Asthma and wheezing begin early in life, and prenatal vitamin D deficiency has been variably associated with these disorders in offspring.
Objective
To determine whether prenatal vitamin D (cholecalciferol) supplementation can prevent asthma or recurrent wheeze in early childhood.
Design, setting, and participants
The Vitamin D Antenatal Asthma Reduction Trial was a randomized, double-blind, placebo-controlled trial conducted in 3 centers across the United States. Enrollment began in October 2009 and completed follow-up in January 2015. Eight hundred eighty-one pregnant women between the ages of 18 and 39 years at high risk of having children with asthma were randomized at 10 to 18 weeks' gestation. Five participants were deemed ineligible shortly after randomization and were discontinued.
Interventions
Four hundred forty women were randomized to receive daily 4000 IU vitamin D plus a prenatal vitamin containing 400 IU vitamin D, and 436 women were randomized to receive a placebo plus a prenatal vitamin containing 400 IU vitamin D.
Main outcomes and measures
Coprimary outcomes of (1) parental report of physician-diagnosed asthma or recurrent wheezing through 3 years of age and (2) third trimester maternal 25-hydroxyvitamin D levels.
Results
Eight hundred ten infants were born in the study, and 806 were included in the analyses for the 3-year outcomes. Two hundred eighteen children developed asthma or recurrent wheeze: 98 of 405 (24.3%; 95% CI, 18.7%-28.5%) in the 4400-IU group vs 120 of 401 (30.4%, 95% CI, 25.7%-73.1%) in the 400-IU group (hazard ratio, 0.8; 95% CI, 0.6-1.0; P = .051). Of the women in the 4400-IU group whose blood levels were checked, 289 (74.9%) had 25-hydroxyvitamin D levels of 30 ng/mL or higher by the third trimester of pregnancy compared with 133 of 391 (34.0%) in the 400-IU group (difference, 40.9%; 95% CI, 34.2%-47.5%, P < .001).
Conclusions and relevance
In pregnant women at risk of having a child with asthma, supplementation with 4400 IU/d of vitamin D compared with 400 IU/d significantly increased vitamin D levels in the women. The incidence of asthma and recurrent wheezing in their children at age 3 years was lower by 6.1%, but this did not meet statistical significance; however, the study may have been underpowered. Longer follow-up of the children is ongoing to determine whether the difference is clinically important.
Trial registration
clinicaltrials.gov Identifier: NCT00920621.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
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