Cargando…
Efficacy and safety of vitamin D supplementation in hospitalized COVID-19 pediatric patients: A randomized controlled trial
BACKGROUND: Some studies suggested that adequate levels of vitamin D (VD) decrease the risk of severe COVID-19. Information about the effectiveness of VD supplementation in children is scarce. OBJECTIVE: To assess the efficacy and safety of VD supplementation compared to the standard of care in hosp...
Autores principales: | , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Frontiers Media S.A.
2022
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9357919/ https://www.ncbi.nlm.nih.gov/pubmed/35958172 http://dx.doi.org/10.3389/fped.2022.943529 |
_version_ | 1784763815236206592 |
---|---|
author | Zurita-Cruz, Jessie Fonseca-Tenorio, Jeffry Villasís-Keever, Miguel López-Alarcón, Mardia Parra-Ortega, Israel López-Martínez, Briceida Miranda-Novales, Guadalupe |
author_facet | Zurita-Cruz, Jessie Fonseca-Tenorio, Jeffry Villasís-Keever, Miguel López-Alarcón, Mardia Parra-Ortega, Israel López-Martínez, Briceida Miranda-Novales, Guadalupe |
author_sort | Zurita-Cruz, Jessie |
collection | PubMed |
description | BACKGROUND: Some studies suggested that adequate levels of vitamin D (VD) decrease the risk of severe COVID-19. Information about the effectiveness of VD supplementation in children is scarce. OBJECTIVE: To assess the efficacy and safety of VD supplementation compared to the standard of care in hospitalized children with COVID-19. PATIENTS AND METHODS: An open-label randomized controlled single-blind clinical trial was carried out. We included patients from 1 month to 17 years, with moderate COVID-19, who required hospitalization and supplemental oxygen. They were randomized into two groups: the VD group, which received doses of 1,000 (children < 1 year) or 2,000 IU/day (from 1 to 17 years) and the group without VD (control). The outcome variables were the progression of oxygen requirement, the development of complications, and death. STATISTICAL ANALYSIS: For comparison between groups, we used the chi-squared test or Fisher's exact test and the Mann–Whitney U test. Absolute risk reduction (ARR) and the number needed to treat (NNT) were calculated. p ≤ 0.05 was considered statistically significant. RESULTS: From 24 March 2020 to 31 March 2021, 87 patients were eligible to participate in the trial; 45 patients were randomized: 20 to the VD group and 25 to the control group. There was no difference in general characteristics at baseline, including serum VD levels (median 13.8 ng/ml in the VD group and 11.4 ng/ml in the control group). OUTCOMES: 2/20 (10%) in the VD group vs. 9/25 (36%) in the control group progressed to a superior ventilation modality (p = 0.10); one patient in the VD group died (5%) compared to 6 (24%) patients in the control group (p = 0.23). ARR was 26% (95% CI 8.8 to 60.2%) and NNT was 3 (2 to 11) for progression and ARR was 19% (95% CI −3.9 to 42.8%) and NNT was 6 (2 to 26) for death. None of the patients receiving VD had adverse effects. The trial was stopped for ethical reasons; since after receiving the results of the basal VD values, none of the patients had normal levels. CONCLUSION: In this trial, VD supplementation in pediatric patients seems to decrease the risk of COVID-19 progression and death. More studies are needed to confirm these findings. CLINICAL TRIAL REGISTRATION: This protocol was registered on ClinicalTrials.gov with the registration number NCT04502667. |
format | Online Article Text |
id | pubmed-9357919 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Frontiers Media S.A. |
record_format | MEDLINE/PubMed |
spelling | pubmed-93579192022-08-10 Efficacy and safety of vitamin D supplementation in hospitalized COVID-19 pediatric patients: A randomized controlled trial Zurita-Cruz, Jessie Fonseca-Tenorio, Jeffry Villasís-Keever, Miguel López-Alarcón, Mardia Parra-Ortega, Israel López-Martínez, Briceida Miranda-Novales, Guadalupe Front Pediatr Pediatrics BACKGROUND: Some studies suggested that adequate levels of vitamin D (VD) decrease the risk of severe COVID-19. Information about the effectiveness of VD supplementation in children is scarce. OBJECTIVE: To assess the efficacy and safety of VD supplementation compared to the standard of care in hospitalized children with COVID-19. PATIENTS AND METHODS: An open-label randomized controlled single-blind clinical trial was carried out. We included patients from 1 month to 17 years, with moderate COVID-19, who required hospitalization and supplemental oxygen. They were randomized into two groups: the VD group, which received doses of 1,000 (children < 1 year) or 2,000 IU/day (from 1 to 17 years) and the group without VD (control). The outcome variables were the progression of oxygen requirement, the development of complications, and death. STATISTICAL ANALYSIS: For comparison between groups, we used the chi-squared test or Fisher's exact test and the Mann–Whitney U test. Absolute risk reduction (ARR) and the number needed to treat (NNT) were calculated. p ≤ 0.05 was considered statistically significant. RESULTS: From 24 March 2020 to 31 March 2021, 87 patients were eligible to participate in the trial; 45 patients were randomized: 20 to the VD group and 25 to the control group. There was no difference in general characteristics at baseline, including serum VD levels (median 13.8 ng/ml in the VD group and 11.4 ng/ml in the control group). OUTCOMES: 2/20 (10%) in the VD group vs. 9/25 (36%) in the control group progressed to a superior ventilation modality (p = 0.10); one patient in the VD group died (5%) compared to 6 (24%) patients in the control group (p = 0.23). ARR was 26% (95% CI 8.8 to 60.2%) and NNT was 3 (2 to 11) for progression and ARR was 19% (95% CI −3.9 to 42.8%) and NNT was 6 (2 to 26) for death. None of the patients receiving VD had adverse effects. The trial was stopped for ethical reasons; since after receiving the results of the basal VD values, none of the patients had normal levels. CONCLUSION: In this trial, VD supplementation in pediatric patients seems to decrease the risk of COVID-19 progression and death. More studies are needed to confirm these findings. CLINICAL TRIAL REGISTRATION: This protocol was registered on ClinicalTrials.gov with the registration number NCT04502667. Frontiers Media S.A. 2022-07-25 /pmc/articles/PMC9357919/ /pubmed/35958172 http://dx.doi.org/10.3389/fped.2022.943529 Text en Copyright © 2022 Zurita-Cruz, Fonseca-Tenorio, Villasís-Keever, López-Alarcón, Parra-Ortega, López-Martínez and Miranda-Novales. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms. |
spellingShingle | Pediatrics Zurita-Cruz, Jessie Fonseca-Tenorio, Jeffry Villasís-Keever, Miguel López-Alarcón, Mardia Parra-Ortega, Israel López-Martínez, Briceida Miranda-Novales, Guadalupe Efficacy and safety of vitamin D supplementation in hospitalized COVID-19 pediatric patients: A randomized controlled trial |
title | Efficacy and safety of vitamin D supplementation in hospitalized COVID-19 pediatric patients: A randomized controlled trial |
title_full | Efficacy and safety of vitamin D supplementation in hospitalized COVID-19 pediatric patients: A randomized controlled trial |
title_fullStr | Efficacy and safety of vitamin D supplementation in hospitalized COVID-19 pediatric patients: A randomized controlled trial |
title_full_unstemmed | Efficacy and safety of vitamin D supplementation in hospitalized COVID-19 pediatric patients: A randomized controlled trial |
title_short | Efficacy and safety of vitamin D supplementation in hospitalized COVID-19 pediatric patients: A randomized controlled trial |
title_sort | efficacy and safety of vitamin d supplementation in hospitalized covid-19 pediatric patients: a randomized controlled trial |
topic | Pediatrics |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9357919/ https://www.ncbi.nlm.nih.gov/pubmed/35958172 http://dx.doi.org/10.3389/fped.2022.943529 |
work_keys_str_mv | AT zuritacruzjessie efficacyandsafetyofvitamindsupplementationinhospitalizedcovid19pediatricpatientsarandomizedcontrolledtrial AT fonsecatenoriojeffry efficacyandsafetyofvitamindsupplementationinhospitalizedcovid19pediatricpatientsarandomizedcontrolledtrial AT villasiskeevermiguel efficacyandsafetyofvitamindsupplementationinhospitalizedcovid19pediatricpatientsarandomizedcontrolledtrial AT lopezalarconmardia efficacyandsafetyofvitamindsupplementationinhospitalizedcovid19pediatricpatientsarandomizedcontrolledtrial AT parraortegaisrael efficacyandsafetyofvitamindsupplementationinhospitalizedcovid19pediatricpatientsarandomizedcontrolledtrial AT lopezmartinezbriceida efficacyandsafetyofvitamindsupplementationinhospitalizedcovid19pediatricpatientsarandomizedcontrolledtrial AT mirandanovalesguadalupe efficacyandsafetyofvitamindsupplementationinhospitalizedcovid19pediatricpatientsarandomizedcontrolledtrial |