Effect of Vitamin D3 Supplementation on Severe Asthma Exacerbations in Children With Asthma and Low Vitamin D Levels: The VDKA Randomized Clinical Trial
Forno E, Bacharier LB, Phipatanakul W, Guilbert TW, Cabana MD, Ross K, Covar R, Gern JE, Rosser FJ, Blatter J, Durrani S, Han YY, Wisniewski SR, Celedón JC
JAMA · 121 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 Center for Advancing Translational Sciences
- Gobierno
- NCATS NIH HHS
- Subvenciones
- National Center for Advancing Translational Sciences (UL1‐TR‐001857)
Según 2 financiadores declarados.
Publicación
- Publicado
- 2020-08-25 · JAMA · vol. 324 · número 8 · pág. 752
- Editorial
- American Medical Association
- Citado
- 168 citas · más que el 99% de estudios similares · 13.6× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 28 trabajos
- Acceso
- Lectura gratuita
- Áreas de investigación
- Vitamin D Research Studies · Asthma and respiratory diseases · Vitamin C and Antioxidants Research
- Palabras clave
- Medicine, Fluticasone propionate, Asthma, Exacerbation, Vitamin D and neurology, Randomized controlled trial, Placebo, Fluticasone, Pediatrics, Internal medicine, vitamin D deficiency, Corticosteroid, Asthma exacerbations
- MeSH
- humans, asthma, vitamin d deficiency, cholecalciferol, adrenal cortex hormones, vitamins, vitamin d, treatment failure, double-blind method, dietary supplements, adolescent, child, female, male, symptom flare up
14 autores
- Erick Forno🇺🇸Children's Hospital of Pittsburgh; University of Pittsburgh Medical Center
- Leonard B. Bacharier🇺🇸St. Louis Children's Hospital
- Wanda Phipatanakul🇺🇸Boston Children's Hospital; Harvard University
- Theresa W. Guilbert🇺🇸Cincinnati Children's Hospital Medical Center; University of Cincinnati
- Michael D. Cabana🇺🇸University of California, San Francisco; UCSF Benioff Children's Hospital
- Kristie R. Ross🇺🇸Rainbow Babies & Children's Hospital; Case Western Reserve University
- Ronina A. Covar🇺🇸National Jewish Health; University of Colorado Denver
- James E. Gern🇺🇸University of Wisconsin–Madison
- Franziska J. Rosser🇺🇸Children's Hospital of Pittsburgh; University of Pittsburgh Medical Center
- Joshua A. Blatter🇺🇸St. Louis Children's Hospital
- Sandy R. Durrani🇺🇸Cincinnati Children's Hospital Medical Center; University of Cincinnati
- Yueh‐Ying Han🇺🇸Children's Hospital of Pittsburgh; University of Pittsburgh Medical Center
- Stephen R. Wisniewski🇺🇸University of Pittsburgh
- Juan Carlos Celedon🇺🇸 · autor de correspondenciaChildren's Hospital of Pittsburgh; University of Pittsburgh Medical Center
Resumen
El texto original del estudio, en el idioma en que se publicó.
Importance
Severe asthma exacerbations cause significant morbidity and costs. Whether vitamin D3 supplementation reduces severe childhood asthma exacerbations is unclear.
Objective
To determine whether vitamin D3 supplementation improves the time to a severe exacerbation in children with asthma and low vitamin D levels.
Design, setting, and participants
The Vitamin D to Prevent Severe Asthma Exacerbations (VDKA) Study was a randomized, double-blind, placebo-controlled clinical trial of vitamin D3 supplementation to improve the time to severe exacerbations in high-risk children with asthma aged 6 to 16 years taking low-dose inhaled corticosteroids and with serum 25-hydroxyvitamin D levels less than 30 ng/mL. Participants were recruited from 7 US centers. Enrollment started in February 2016, with a goal of 400 participants; the trial was terminated early (March 2019) due to futility, and follow-up ended in September 2019.
Interventions
Participants were randomized to vitamin D3, 4000 IU/d (n = 96), or placebo (n = 96) for 48 weeks and maintained with fluticasone propionate, 176 μg/d (6-11 years old), or 220 μg/d (12-16 years old).
Main outcomes and measures
The primary outcome was the time to a severe asthma exacerbation. Secondary outcomes included the time to a viral-induced severe exacerbation, the proportion of participants in whom the dose of inhaled corticosteroid was reduced halfway through the trial, and the cumulative fluticasone dose during the trial.
Results
Among 192 randomized participants (mean age, 9.8 years; 77 girls [40%]), 180 (93.8%) completed the trial. A total of 36 participants (37.5%) in the vitamin D3 group and 33 (34.4%) in the placebo group had 1 or more severe exacerbations. Compared with placebo, vitamin D3 supplementation did not significantly improve the time to a severe exacerbation: the mean time to exacerbation was 240 days in the vitamin D3 group vs 253 days in the placebo group (mean group difference, -13.1 days [95% CI, -42.6 to 16.4]; adjusted hazard ratio, 1.13 [95% CI, 0.69 to 1.85]; P = .63). Vitamin D3 supplementation, compared with placebo, likewise did not significantly improve the time to a viral-induced severe exacerbation, the proportion of participants whose dose of inhaled corticosteroid was reduced, or the cumulative fluticasone dose during the trial. Serious adverse events were similar in both groups (vitamin D3 group, n = 11; placebo group, n = 9).
Conclusions and relevance
Among children with persistent asthma and low vitamin D levels, vitamin D3 supplementation, compared with placebo, did not significantly improve the time to a severe asthma exacerbation. The findings do not support the use of vitamin D3 supplementation to prevent severe asthma exacerbations in this group of patients.
Trial registration
ClinicalTrials.gov Identifier: NCT02687815.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
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