Effect of Vitamin D3 Supplementation During Pregnancy on Risk of Persistent Wheeze in the Offspring: A Randomized Clinical Trial
Chawes BL, Bønnelykke K, Stokholm J, Vissing NH, Bjarnadóttir E, Schoos AM, Wolsk HM, Pedersen TM, Vinding RK, Thorsteinsdóttir S, Arianto L, Hallas HW, Heickendorff L, Brix S, Rasmussen MA, Bisgaard H
JAMA · 271 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
- Posiblemente financiado por la industria
- Organización sin fines de lucro
- Lundbeckfonden
- Empresa
- Lundbeck Foundation
- Subvenciones
- Lundbeckfonden (R191-2015.1571)
Según 2 financiadores declarados.
Publicación
- Publicado
- 2016-01-26 · JAMA · vol. 315 · número 4 · pág. 353
- Editorial
- American Medical Association
- Citado
- 340 citas · más que el 100% de estudios similares · 33.4× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 43 trabajos
- Acceso
- Lectura gratuita
- Áreas de investigación
- Vitamin D Research Studies · Asthma and respiratory diseases · Pregnancy and Medication Impact
- Palabras clave
- Medicine, Wheeze, Pregnancy, Offspring, Pediatrics, Asthma, Vitamin D and neurology, Vitamin, Randomized controlled trial, Cohort study, Cohort, Respiratory tract infections, Obstetrics, Internal medicine, Respiratory system
- MeSH
- humans, asthma, respiratory sounds, cholecalciferol, vitamins, vitamin d, double-blind method, pregnancy, pregnancy trimester, third, adult, child, preschool, infant, infant, newborn, female
16 autores
- Bo Chawes🇩🇰University of Copenhagen; Gentofte Hospital; Copenhagen Prospective Studies on Asthma in Childhood
- Klaus Bønnelykke🇩🇰University of Copenhagen; Gentofte Hospital; Copenhagen Prospective Studies on Asthma in Childhood
- Jakob Stokholm🇩🇰University of Copenhagen; Gentofte Hospital; Næstved Sygehus; Copenhagen Prospective Studies on Asthma in Childhood
- Nadja Hawwa Vissing🇩🇰University of Copenhagen; Gentofte Hospital; Copenhagen Prospective Studies on Asthma in Childhood
- Elín Bjarnadóttir🇩🇰University of Copenhagen; Gentofte Hospital; Næstved Sygehus; Copenhagen Prospective Studies on Asthma in Childhood
- Ann‐Marie Malby Schoos🇩🇰University of Copenhagen; Gentofte Hospital; Copenhagen Prospective Studies on Asthma in Childhood
- Helene Mygind Wolsk🇩🇰University of Copenhagen; Gentofte Hospital; Copenhagen Prospective Studies on Asthma in Childhood
- Tine Marie Pedersen🇩🇰University of Copenhagen; Gentofte Hospital; Næstved Sygehus; Copenhagen Prospective Studies on Asthma in Childhood
- Rebecca Vinding🇩🇰University of Copenhagen; Gentofte Hospital; Næstved Sygehus; Copenhagen Prospective Studies on Asthma in Childhood
- Sunna Thorsteinsdóttir🇩🇰University of Copenhagen; Gentofte Hospital; Copenhagen Prospective Studies on Asthma in Childhood
- Lambang Arianto🇩🇰University of Copenhagen; Gentofte Hospital; Copenhagen Prospective Studies on Asthma in Childhood
- Henrik Wegener Hallas🇩🇰University of Copenhagen; Gentofte Hospital; Copenhagen Prospective Studies on Asthma in Childhood
- Lene Heickendorff🇩🇰Aarhus University Hospital
- Susanne Brix🇩🇰Technical University of Denmark
- Morten Arendt Rasmussen🇩🇰University of Copenhagen; Gentofte Hospital; Copenhagen Prospective Studies on Asthma in Childhood
- Hans Bisgaard🇩🇰 · autor de correspondenciaUniversity of Copenhagen; Gentofte Hospital; Copenhagen Prospective Studies on Asthma in Childhood
Resumen
El texto original del estudio, en el idioma en que se publicó.
Importance
Observational studies have suggested that increased dietary vitamin D intake during pregnancy may protect against wheezing in the offspring, but the preventive effect of vitamin D supplementation to pregnant women is unknown.
Objective
To determine whether supplementation of vitamin D3 during the third trimester of pregnancy reduces the risk of persistent wheeze in the offspring.
Design, setting, and participants
A double-blind, single-center, randomized clinical trial conducted within the Copenhagen Prospective Studies on Asthma in Childhood 2010 cohort. Enrollment began March 2009 with a goal of 708 participants, but due to delayed ethical approval, only 623 women were recruited at 24 weeks of pregnancy. Follow-up of the children (N = 581) was completed when the youngest child reached age 3 years in March 2014.
Interventions
Vitamin D3 (2400 IU/d; n = 315) or matching placebo tablets (n = 308) from pregnancy week 24 to 1 week postpartum. All women received 400 IU/d of vitamin D3 as part of usual pregnancy care.
Main outcomes and measures
Age at onset of persistent wheeze in the first 3 years of life. Secondary outcomes included number of episodes of troublesome lung symptoms, asthma, respiratory tract infections, and neonatal airway immunology. Adverse events were assessed.
Results
Of the 581 children, persistent wheeze was diagnosed during the first 3 years of life in 47 children (16%) in the vitamin D3 group and 57 children (20%) in the control group. Vitamin D3 supplementation was not associated with the risk of persistent wheeze, but the number of episodes of troublesome lung symptoms was reduced, and the airway immune profile was up-regulated (principal component analysis, P = .04). There was no effect on additional end points. Intrauterine death was observed in 1 fetus (<1%) in the vitamin D3 group vs 3 fetuses (1%) in the control group and congenital malformations in 17 neonates (5%) in the vitamin D3 group vs 23 neonates (8%) in the control group. [table: see text].
Conclusions and relevance
The use of 2800 IU/d of vitamin D3 during the third trimester of pregnancy compared with 400 IU/d did not result in a statistically significant reduced risk of persistent wheeze in the offspring through age 3 years. However, interpretation of the study is limited by a wide CI that includes a clinically important protective effect.
Trial registration
clinicaltrials.gov Identifier: NCT00856947.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
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