Effect of moderate or high versus low dose daily vitamin D on COVID-19 incidence: A double-blind, parallel-group randomized clinical trial
Meltzer DO, Moy JN, Schram AW, Tate A, Hyman MJ, Cursio JF, Vokes T, Yeo KJ, Prochaska M, Jacobs JJ, Solway J
Clinical nutrition (Edinburgh, Scotland) · 0 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
- Mississippi Division of Medicaid
- Organización sin fines de lucro
- Ingalls Development Foundation
- Gobierno
- National Institutes of Health
- Gobierno
- National Center for Advancing Translational Sciences
- Gobierno
- NCATS NIH HHS
- Subvenciones
- National Center for Advancing Translational Sciences (UL1-TR002389)
Según 5 financiadores declarados.
Publicación
- Publicado
- 2026-07-04 · Clin Nutr · vol. 64 · pág. 106722
- Editorial
- Elsevier BV
- Citado
- 0 citas · más que el 50% de estudios similares · 0.0× el promedio de su campo
- Referencias
- 28 trabajos
- Acceso
- Acceso abierto (copia en repositorio)
- Áreas de investigación
- Vitamin D Research Studies · SARS-CoV-2 and COVID-19 Research · COVID-19 Clinical Research Studies
- Palabras clave
- vitamin D supplementation, COVID-19 incidence, vitamin D dose, 25-hydroxyvitamin D, immune function, vitamin D deficiency, SARS-CoV-2 infection risk, COVID-19 prevention
- MeSH
- humans, vitamin d deficiency, vitamins, vitamin d, incidence, double-blind method, dose-response relationship, drug, dietary supplements, adult, aged, middle aged, female, male, covid-19, sars-cov-2
11 autores
- David O. Meltzer🇺🇸 · autor de correspondenciaUniversity of Chicago
- James N. Moy🇺🇸Rush University Medical Center; Rush University
- Andrew W. Schram🇺🇸University of Chicago
- Alexandra Tate🇺🇸University of Chicago
- Max J. Hyman🇺🇸University of Chicago
- John Cursio🇺🇸University of Chicago
- Tamara Vokes🇺🇸University of Chicago
- Kiang-Teck J. Yeo🇺🇸University of Chicago
- Micah T. Prochaska🇺🇸University of Chicago
- Joshua James Jacobs🇺🇸Rush University Medical Center
- Julian Solway🇺🇸University of Chicago
Resumen
El texto original del estudio, en el idioma en que se publicó.
Background & aims
Vitamin D affects immune function and is associated with lower COVID-19 risk in observational studies. However, randomized clinical trials vary in whether they find vitamin D supplementation affects COVID-19 risk. The objective of this trial was to determine whether moderate or high dose vitamin D (4000 or 10,000 IU/day) versus low dose vitamin D (400 IU/day) affects COVID-19 risk.
Methods
We conducted a double-blind, parallel-group randomized trial (clinicaltrials.gov, NCT0486890) enrolling participants from December 5, 2020 to May 23, 2023 who chose between study branches comparing moderate versus low dose or high versus low dose vitamin D for up to 9 months and were randomized between the doses in their chosen branch. Recruitment occurred at UChicago Medicine or Rush University Medical Center. Eligibility criteria excluded persons with increased risk from vitamin D supplementation. Recruitment concluded March 30, 2023, with 955 participants randomized, and 923 continuing their participation until receipt of study vitamin D, including 324 high-versus-low branch participants. The primary outcome was time from randomization to COVID-19 infection.
Results
COVID-19 risk was not lower for pooled moderate or high versus low dose (10.9% (50/461) versus 14.7% (68/462), aHR:0.73; 95%-CI:0.51-1.06; P = 0.10). In prespecified secondary analyses, COVID-19 risk was lower for moderate versus low dose (aHR:0.62; 95%-CI:0.39-0.99; P = 0.045) but not high versus low dose (aHR:0.99; 95%-CI:0.53-1.86; P = 0.98). Prespecified time-varying analyses controlling for post-randomization 25(OH)D levels found similar treatment effects, with no effects of 25(OH)D levels on risk. In a final prespecified analysis, among 130 seroconverting participants, COVID-19 was not reported less for pooled moderate or high versus low dose (aOR:0.62; 95%-CI:0.27-1.41; P = 0.25) and moderate versus low dose (aOR:0.37; 95%-CI:0.13-1.04; P = 0.06).
Conclusion
Moderate or high versus low dose vitamin D supplementation did not decrease COVID-19 risk, but effects may vary by dose. Further study is warranted of the effects of higher doses and 25(OH)D levels on COVID-19 and other viral respiratory tract infections, and whether these infections become clinically evident.
Trial registration
clinicaltrials.gov, NCT04868903, https://clinicaltrials.gov/study/NCT04868903.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
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