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Efficacy and Safety of Vitamin D Supplementation to Prevent COVID-19 in Frontline Healthcare Workers. A Randomized Clinical Trial.
Arch Med Res. 2022 Jun; 53(4):423-430.AM

Abstract

BACKGROUND

Associations between vitamin D (VD) deficiency and the risk of SARS-CoV-2 infection have been documented in cross-sectional population studies. Intervention studies in patients with moderate to severe COVID-19 have failed to consistently document a beneficial effect.

OBJECTIVE

To determine the efficacy and safety of VD-supplementation in the prevention of SARS-CoV-2 infection in highly exposed individuals.

METHODS

A double-blind, parallel, randomized trial was conducted. Frontline healthcare workers from four hospitals in Mexico City, who tested negative for SARS-CoV-2 infection, were enrolled between July 15 and December 30, 2020. Participants were randomly assigned to receive 4,000 IU VD (VDG) or placebo (PG) daily for 30 d. RT-PCR tests were taken at baseline and repeated if COVID-19 manifestations appeared during follow-up. Serum 25-hydroxyvitamin D3 and antibody tests were measured at baseline and at day 45. Per-protocol and intention-to-treat analysis were conducted.

RESULTS

Of 321 recruited subjects, 94 VDG and 98 PG completed follow-up. SARS-CoV-2 infection rate was lower in VDG than in PG (6.4 vs. 24.5%, p <0.001). The risk of acquiring SARS-CoV-2 infection was lower in the VDG than in the PG (RR: 0.23; 95% CI: 0.09-0.55) and was associated with an increment in serum levels of 25-hydroxyvitamin D3 (RR: 0.87; 95% CI: 0.82-0.93), independently of VD deficiency. No significant adverse events were identified.

CONCLUSIONS

Our results suggest that VD-supplementation in highly exposed individuals prevents SARS-CoV-2 infection without serious AEs and regardless of VD status.

Authors+Show Affiliations

Unidad de Investigación en Análisis y Síntesis de la Evidencia, Centro Médico Nacional Siglo XXI, Instituto Mexicano del Seguro Social, Ciudad de México, México.Unidad de Investigación Médica en Nutrición, Centro Médico Nacional Siglo XXI, Instituto Mexicano del Seguro Social, Ciudad de México, México. Electronic address: mardyalo@hotmail.com.Unidad de Investigación en Análisis y Síntesis de la Evidencia, Centro Médico Nacional Siglo XXI, Instituto Mexicano del Seguro Social, Ciudad de México, México.Facultad de Medicina, Universidad Nacional Autónoma de México; Hospital Infantil de México Federico Gómez, Ciudad de México, México.Unidad de Investigación Médica en Nutrición, Centro Médico Nacional Siglo XXI, Instituto Mexicano del Seguro Social, Ciudad de México, México.Coordinación de Investigación en Salud, Instituto Mexicano del Seguro Social, Ciudad de México, México.Unidad de Investigación Médica en Nutrición, Centro Médico Nacional Siglo XXI, Instituto Mexicano del Seguro Social, Ciudad de México, México.Laboratorio Central de Epidemiología, Centro Médico Nacional La Raza, Instituto Mexicano del Seguro Social, Ciudad de México, México.Laboratorio Central de Epidemiología, Centro Médico Nacional La Raza, Instituto Mexicano del Seguro Social, Ciudad de México, México.Laboratorio Central de Epidemiología, Centro Médico Nacional La Raza, Instituto Mexicano del Seguro Social, Ciudad de México, México.Unidad de Investigación Médica en Nutrición, Centro Médico Nacional Siglo XXI, Instituto Mexicano del Seguro Social, Ciudad de México, México.Unidad de Investigación Médica en Nutrición, Centro Médico Nacional Siglo XXI, Instituto Mexicano del Seguro Social, Ciudad de México, México.Hospital Infantil de México Federico Gómez, Ciudad de México, México.Hospital Infantil de México Federico Gómez, Ciudad de México, México.Hospital Infantil de México Federico Gómez, Ciudad de México, México.Hospital Infantil de México Federico Gómez, Ciudad de México, México.

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

35487792

Citation

Villasis-Keever, Miguel A., et al. "Efficacy and Safety of Vitamin D Supplementation to Prevent COVID-19 in Frontline Healthcare Workers. a Randomized Clinical Trial." Archives of Medical Research, vol. 53, no. 4, 2022, pp. 423-430.
Villasis-Keever MA, López-Alarcón MG, Miranda-Novales G, et al. Efficacy and Safety of Vitamin D Supplementation to Prevent COVID-19 in Frontline Healthcare Workers. A Randomized Clinical Trial. Arch Med Res. 2022;53(4):423-430.
Villasis-Keever, M. A., López-Alarcón, M. G., Miranda-Novales, G., Zurita-Cruz, J. N., Barrada-Vázquez, A. S., González-Ibarra, J., Martínez-Reyes, M., Grajales-Muñiz, C., Santacruz-Tinoco, C. E., Martínez-Miguel, B., Maldonado-Hernández, J., Cifuentes-González, Y., Klünder-Klünder, M., Garduño-Espinosa, J., López-Martínez, B., & Parra-Ortega, I. (2022). Efficacy and Safety of Vitamin D Supplementation to Prevent COVID-19 in Frontline Healthcare Workers. A Randomized Clinical Trial. Archives of Medical Research, 53(4), 423-430. https://doi.org/10.1016/j.arcmed.2022.04.003
Villasis-Keever MA, et al. Efficacy and Safety of Vitamin D Supplementation to Prevent COVID-19 in Frontline Healthcare Workers. a Randomized Clinical Trial. Arch Med Res. 2022;53(4):423-430. PubMed PMID: 35487792.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and Safety of Vitamin D Supplementation to Prevent COVID-19 in Frontline Healthcare Workers. A Randomized Clinical Trial. AU - Villasis-Keever,Miguel A, AU - López-Alarcón,Mardia G, AU - Miranda-Novales,Guadalupe, AU - Zurita-Cruz,Jessie N, AU - Barrada-Vázquez,Aly S, AU - González-Ibarra,Joaquín, AU - Martínez-Reyes,Monserrat, AU - Grajales-Muñiz,Concepción, AU - Santacruz-Tinoco,Clara E, AU - Martínez-Miguel,Bernardo, AU - Maldonado-Hernández,Jorge, AU - Cifuentes-González,Yazmín, AU - Klünder-Klünder,Miguel, AU - Garduño-Espinosa,Juan, AU - López-Martínez,Briseida, AU - Parra-Ortega,Israel, Y1 - 2022/04/18/ PY - 2022/02/28/received PY - 2022/03/25/revised PY - 2022/04/11/accepted PY - 2022/4/30/pubmed PY - 2022/5/31/medline PY - 2022/4/29/entrez KW - 25-hydroxyvitamin D3 KW - COVID-19 KW - Healthcare workers KW - SARS-CoV-2 KW - Vitamin D SP - 423 EP - 430 JF - Archives of medical research JO - Arch Med Res VL - 53 IS - 4 N2 - BACKGROUND: Associations between vitamin D (VD) deficiency and the risk of SARS-CoV-2 infection have been documented in cross-sectional population studies. Intervention studies in patients with moderate to severe COVID-19 have failed to consistently document a beneficial effect. OBJECTIVE: To determine the efficacy and safety of VD-supplementation in the prevention of SARS-CoV-2 infection in highly exposed individuals. METHODS: A double-blind, parallel, randomized trial was conducted. Frontline healthcare workers from four hospitals in Mexico City, who tested negative for SARS-CoV-2 infection, were enrolled between July 15 and December 30, 2020. Participants were randomly assigned to receive 4,000 IU VD (VDG) or placebo (PG) daily for 30 d. RT-PCR tests were taken at baseline and repeated if COVID-19 manifestations appeared during follow-up. Serum 25-hydroxyvitamin D3 and antibody tests were measured at baseline and at day 45. Per-protocol and intention-to-treat analysis were conducted. RESULTS: Of 321 recruited subjects, 94 VDG and 98 PG completed follow-up. SARS-CoV-2 infection rate was lower in VDG than in PG (6.4 vs. 24.5%, p <0.001). The risk of acquiring SARS-CoV-2 infection was lower in the VDG than in the PG (RR: 0.23; 95% CI: 0.09-0.55) and was associated with an increment in serum levels of 25-hydroxyvitamin D3 (RR: 0.87; 95% CI: 0.82-0.93), independently of VD deficiency. No significant adverse events were identified. CONCLUSIONS: Our results suggest that VD-supplementation in highly exposed individuals prevents SARS-CoV-2 infection without serious AEs and regardless of VD status. SN - 1873-5487 UR - https://www.unboundmedicine.com/medline/citation/35487792/full_citation DB - PRIME DP - Unbound Medicine ER -