Efficacy and safety of vitamin D supplementation in hospitalized COVID-19 pediatric patients: A randomized controlled trial
Por:
Zurita-Cruz, Jessie, Fonseca-Tenorio, Jeffry, Villasis-Keever, Miguel, Lopez-Alarcon, Mardia, Parra-Ortega, Israel, Lopez-Martinez, Briceida, Miranda-Novales, Guadalupe
Publicada:
25 jul 2022
Categoría:
Pediatrics, perinatology and child health
Resumen:
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 & LE; 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.
Filiaciones:
Zurita-Cruz, Jessie:
Univ Nacl Autonoma Mexico, Pediat Hosp Feder Gomez, Fac Med, Mexico City, Mexico
Fonseca-Tenorio, Jeffry:
Mexican Inst Social Secur, Natl Med Ctr, Infect Dis Dept, Century 21,Pediat Hosp, Mexico City, Mexico
Villasis-Keever, Miguel:
Mexican Inst Social Secur, Natl Med Ctr Century 21, Anal & Synth Evidence Res Unit, Mexico City, Mexico
Lopez-Alarcon, Mardia:
Mexican Inst Social Secur, Natl Med Ctr, Med Nutr Res Unit, Century 21,Pediat Hosp, Mexico City, Mexico
Parra-Ortega, Israel:
Hosp Infantil Mexico Dr Federico Gomez, Clin Lab Dept, Mexico City, Mexico
Lopez-Martinez, Briceida:
Hosp Infantil Mexico Dr Federico Gomez, Auxiliary Diagnost Serv, Minist Hlth, Mexico City, Mexico
Miranda-Novales, Guadalupe:
Mexican Inst Social Secur, Natl Med Ctr Century 21, Anal & Synth Evidence Res Unit, Mexico City, Mexico
gold, Green Published, Gold, Green
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