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

{ 'indexed': {'date-parts': [[2022, 7, 25]], 'date-time': '2022-07-25T06:42:20Z', 'timestamp': 1658731340098}, 'reference-count': 46, 'publisher': 'Frontiers Media SA', 'license': [ { 'start': { 'date-parts': [[2022, 7, 25]], 'date-time': '2022-07-25T00:00:00Z', 'timestamp': 1658707200000}, 'content-version': 'vor', 'delay-in-days': 0, 'URL': 'https://creativecommons.org/licenses/by/4.0/'}], 'content-domain': {'domain': ['frontiersin.org'], 'crossmark-restriction': True}, 'abstract': '<jats:sec><jats:title>Background</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Objective</jats:title><jats:p>To assess the ' 'efficacy and safety of VD supplementation compared to the standard of care in hospitalized ' 'children with COVID-19.</jats:p></jats:sec><jats:sec><jats:title>Patients and ' 'methods</jats:title><jats:p>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 &amp;lt; 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.</jats:p></jats:sec><jats:sec><jats:title>Statistical analysis</jats:title><jats:p>For ' "comparison between groups, we used the chi-squared test or Fisher's exact test and the " 'Mann–Whitney <jats:italic>U</jats:italic> test. Absolute risk reduction (ARR) and the number ' 'needed to treat (NNT) were calculated. <jats:italic>p</jats:italic> ≤ 0.05 was considered ' 'statistically ' 'significant.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>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).</jats:p></jats:sec><jats:sec><jats:title>Outcomes</jats:title><jats:p>2/20 (10%) in ' 'the VD group vs. 9/25 (36%) in the control group progressed to a superior ventilation ' 'modality (<jats:italic>p</jats:italic> = 0.10); one patient in the VD group died (5%) ' 'compared to 6 (24%) patients in the control group (<jats:italic>p</jats:italic> = 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.</jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Clinical Trial ' 'Registration</jats:title><jats:p>This protocol was registered on ' '<jats:ext-link>ClinicalTrials.gov</jats:ext-link> with the registration number ' 'NCT04502667.</jats:p></jats:sec>', 'DOI': '10.3389/fped.2022.943529', 'type': 'journal-article', 'created': {'date-parts': [[2022, 7, 25]], 'date-time': '2022-07-25T06:26:07Z', 'timestamp': 1658730367000}, 'update-policy': 'http://dx.doi.org/10.3389/crossmark-policy', 'source': 'Crossref', 'is-referenced-by-count': 0, 'title': 'Efficacy and safety of vitamin D supplementation in hospitalized COVID-19 pediatric patients: A ' 'randomized controlled trial', 'prefix': '10.3389', 'volume': '10', 'author': [ {'given': 'Jessie', 'family': 'Zurita-Cruz', 'sequence': 'first', 'affiliation': []}, {'given': 'Jeffry', 'family': 'Fonseca-Tenorio', 'sequence': 'additional', 'affiliation': []}, {'given': 'Miguel', 'family': 'Villasís-Keever', 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