Financiado en parte por Bristol-Myers Squibb, Eli Lilly and Company, Pfizer, GlaxoSmithKline, Novo Nordisk
Effect of High-Dose vs Standard-Dose Wintertime Vitamin D Supplementation on Viral Upper Respiratory Tract Infections in Young Healthy Children
Aglipay M, Birken CS, Parkin PC, Loeb MB, Thorpe K, Chen Y, Laupacis A, Mamdani M, Macarthur C, Hoch JS, Mazzulli T, Maguire JL, TARGet Kids! Collaboration
JAMA · 108 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
- Bristol-Myers Squibb
- Empresa
- Eli Lilly and Company
- Empresa
- Pfizer
- Empresa
- GlaxoSmithKline
- Organización sin fines de lucro
- Thrasher Research Fund
- Empresa
- Novo Nordisk
- Gobierno
- Canadian Institutes of Health Research
Según 7 financiadores declarados.
Publicación
- Publicado
- 2017-07-18 · JAMA · vol. 318 · número 3 · pág. 245
- Editorial
- American Medical Association
- Citado
- 150 citas · más que el 99% de estudios similares · 11.5× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 51 trabajos
- Acceso
- Lectura gratuita
- Áreas de investigación
- Vitamin D Research Studies · Pediatric health and respiratory diseases · Respiratory viral infections research
- Palabras clave
- vitamin D supplementation, high-dose vitamin D, viral upper respiratory tract infection, young children, winter, influenza, 25-hydroxyvitamin D, infection incidence, nasal swabs, healthy children, Canada
- MeSH
- nose, humans, respiratory tract infections, virus diseases, common cold, vitamins, vitamin d, administration, oral, incidence, dose-response relationship, drug, dietary supplements, child, preschool, infant, female, male, influenza, human
12 autores
- Mary Aglipay🇨🇦St. Michael's Hospital
- Catherine S. Birken🇨🇦University of Toronto; Hospital for Sick Children; Sickkids Research Institute
- Patricia C. Parkin🇨🇦University of Toronto; Hospital for Sick Children; Sickkids Research Institute
- Mark B Loeb🇨🇦McMaster University
- Kevin E. Thorpe🇨🇦St. Michael's Hospital; University of Toronto
- Yang Chen🇨🇦St. Michael's Hospital; University of Toronto
- Andreas Laupacis🇨🇦St. Michael's Hospital; University of Toronto; Institute for Clinical Evaluative Sciences
- Muhammad Mamdani🇨🇦St. Michael's Hospital; University of Toronto
- Colin Macarthur🇨🇦University of Toronto; Hospital for Sick Children; Sickkids Research Institute
- Jeffrey S. Hoch🇨🇦🇺🇸St. Michael's Hospital; University of Toronto; University of California, Davis
- Tony Mazzulli🇨🇦Mount Sinai Hospital; University of Toronto
- Jonathon L. Maguire🇨🇦 · autor de correspondenciaSt. Michael's Hospital; University of Toronto; Hospital for Sick Children
Resumen
El texto original del estudio, en el idioma en que se publicó.
Importance
Epidemiological studies support a link between low 25-hydroxyvitamin D levels and a higher risk of viral upper respiratory tract infections. However, whether winter supplementation of vitamin D reduces the risk among children is unknown.
Objective
To determine whether high-dose vs standard-dose vitamin D supplementation reduces the incidence of wintertime upper respiratory tract infections in young children.
Design, setting, and participants
A randomized clinical trial was conducted during the winter months between September 13, 2011, and June 30, 2015, among children aged 1 through 5 years enrolled in TARGet Kids!, a multisite primary care practice-based research network in Toronto, Ontario, Canada.
Interventions
Three hundred forty-nine participants were randomized to receive 2000 IU/d of vitamin D oral supplementation (high-dose group) vs 354 participants who were randomized to receive 400 IU/d (standard-dose group) for a minimum of 4 months between September and May.
Main outcome measures
The primary outcome was the number of laboratory-confirmed viral upper respiratory tract infections based on parent-collected nasal swabs over the winter months. Secondary outcomes included the number of influenza infections, noninfluenza infections, parent-reported upper respiratory tract illnesses, time to first upper respiratory tract infection, and serum 25-hydroxyvitamin D levels at study termination.
Results
Among 703 participants who were randomized (mean age, 2.7 years, 57.7% boys), 699 (99.4%) completed the trial. The mean number of laboratory-confirmed upper respiratory tract infections per child was 1.05 (95% CI, 0.91-1.19) for the high-dose group and 1.03 (95% CI, 0.90-1.16) for the standard-dose group, for a between-group difference of 0.02 (95% CI, -0.17 to 0.21) per child. There was no statistically significant difference in number of laboratory-confirmed infections between groups (incidence rate ratio [RR], 0.97; 95% CI, 0.80-1.16). There was also no significant difference in the median time to the first laboratory-confirmed infection: 3.95 months (95% CI, 3.02-5.95 months) for the high-dose group vs 3.29 months (95% CI, 2.66-4.14 months) for the standard-dose group, or number of parent-reported upper respiratory tract illnesses between groups (625 for high-dose vs 600 for standard-dose groups, incidence RR, 1.01; 95% CI, 0.88-1.16). At study termination, serum 25-hydroxyvitamin D levels were 48.7 ng/mL (95% CI, 46.9-50.5 ng/mL) in the high-dose group and 36.8 ng/mL (95% CI, 35.4-38.2 ng/mL) in the standard-dose group.
Conclusions and relevance
Among healthy children aged 1 to 5 years, daily administration of 2000 IU compared with 400 IU of vitamin D supplementation did not reduce overall wintertime upper respiratory tract infections. These findings do not support the routine use of high-dose vitamin D supplementation in children for the prevention of viral upper respiratory tract infections.
Trial registration
clinicaltrials.gov Identifier: NCT01419262.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
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