Efficacy and safety of vitamin D supplementation in hospitalized COVID-19 pediatric patients: A randomized controlled trial

Abstract

BackgroundSome 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.ObjectiveTo assess the efficacy and safety of VD supplementation compared to the standard of care in hospitalized children with COVID-19.Patients and methodsAn 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 analysisFor 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.ResultsFrom 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).Outcomes2/20 (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.ConclusionIn 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 RegistrationThis protocol was registered on ClinicalTrials.gov with the registration number NCT04502667.

COVID-19 Inflammatory Markers and Vitamin D Relationship in Pediatric Patients

“…As such, it is important to start vitamin D supplementation in children. This point is supported by a more recent randomized controlled trial done by Zurita-Cruz et al [ 49 ].…”

Possible Impact of Vitamin D Status and Supplementation on SARS-CoV-2 Infection Risk and COVID-19 Symptoms in a Cohort of Patients with Inflammatory Bowel Disease

“…These challenges and sources of bias in studying the link between VD concentrations and SARS-CoV-2 epidemiology can explain the widely discordant evidence between studies [ 28 , 29 ]. In fact, while the results from observational cross-sectional studies generally indicate that VD insufficiency is strongly associated with SARS-CoV-2 infection and severity [ 22 , 23 , 28 , 29 , 45 , 46 ], evidence from interventional RCTs on VD supplementation in COVID-19 are more discordant, both in terms of prophylactic [ 29 , 47 ] and therapeutic effectiveness [ 48 , 49 , 50 , 51 ]. In our cohort, the absence of extremely impactful differences in VD status between positive and negative patients and COVID-19 severity classes can also be due to the low frequency of extremely low VD levels among our patients, who in most cases already take VD supplementation (40.6%).…”

A Review: Highlighting the Links between Epigenetics, COVID-19 Infection, and Vitamin D

“…Another study showed that vitamin D supplementation led to only two COVID-19 patients requiring ventilation compared with nine patients in the control group. The vitamin D-supplemented group only had one mortality compared with six in the control group, while the patients supplemented with vitamin D also presented a lower hospital admittance period [ 125 ].…”