Vitamin D levels in the pre- and post-COVID-19 pandemic periods in pediatric patients with chronic kidney disease.

Introduction: Vitamin D (VD) deficiency is common in children with chronic kidney disease (CKD) because of multiple factors. During the coronavirus disease 2019 (COVID-19) pandemic, it increased because of medicine shortage and no enough medical service for patients with non-COVID-19 diseases. Objective: To analyze the effects of the COVID-19 pandemic-related lockdown on the serum levels and status of 25-hydroxyvitamin D3 (25-[OH]D) in children with CKD. Materials and methods: This retrospective study included patients (6-18 years old) who were diagnosed with CKD stage 2-5 and routinely measured for serum VD levels between May 2019 and December 2022. Serum 25-(OH)D levels were measured before, during, and after the pandemic (2019, 2020-2021, and 2022, respectively). The daily dose of cholecalciferol supplementation and the readjustment (if required) were recorded. Results: This study included 171 patients (median age: 12 years). Before the pandemic, the median serum VD level was 25.0 ng/mL (19.3% VD deficiency). Then, VD supplementation was adjusted to 400-1,200 UI daily in 98.8% (n = 169) of patients. During the pandemic, the median VD level decreased to 22.5 ng/mL (43.3% VD deficiency). Hence, the supplementation was readjusted, and after the pandemic, the level was 28.7 ng/mL (18.7% VD deficiency), indicating a statistically significant increase in serum VD levels from the prepandemic period (p = 0.007). Conclusion: Decreased serum VD levels and increased VD deficiency frequency were observed in patients with CKD during the COVID-19 but improved after readjustment of supplementation.

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 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.

Efficacy and Safety of Vitamin D Supplementation to Prevent COVID-19 in Frontline Healthcare Workers. A Randomized Clinical Trial.

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.