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All Studies   Meta Analysis    Recent:   
0 0.5 1 1.5 2+ Mortality 79% Improvement Relative Risk Ventilation 72% ICU admission 73% Vitamin D  Zurita-Cruz et al.  LATE TREATMENT  RCT Is late treatment with vitamin D beneficial for COVID-19? RCT 45 patients in Mexico (March 2020 - March 2021) Lower ICU admission with vitamin D (p=0.0062) c19early.org Zurita-Cruz et al., Frontiers in Pedia.., Jul 2022 Favors vitamin D Favors control

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

Zurita-Cruz et al., Frontiers in Pediatrics, doi:10.3389/fped.2022.943529, NCT04502667
Jul 2022  
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Vitamin D for COVID-19
8th treatment shown to reduce risk in October 2020
 
*, now known with p < 0.00000000001 from 120 studies, recognized in 8 countries.
No treatment is 100% effective. Protocols combine complementary and synergistic treatments. * >10% efficacy in meta analysis with ≥3 clinical studies.
4,100+ studies for 60+ treatments. c19early.org
RCT 45 hospitalized high-risk pediatric patients requiring supplemental oxygen in Mexico, showing lower mortality, ventilation, and intensive care with vitamin D treatment, however there were less severe and critical cases at baseline in the treatment group.
Cholecalciferol was used in this study. Meta analysis shows that late stage treatment with calcitriol / calcifediol (or paricalcitol, alfacalcidol, etc.) is more effective than cholecalciferol: 65% [41‑79%] lower risk vs. 39% [26‑49%] lower risk. Cholecalciferol requires two hydroxylation steps to become activated - first in the liver to calcifediol, then in the kidney to calcitriol. Calcitriol, paricalcitol, and alfacalcidol are active vitamin D analogs that do not require conversion. This allows them to have more rapid onset of action compared to cholecalciferol. The time delay for cholecalciferol to increase serum calcifediol levels can be 2-3 days, and the delay for converting calcifediol to active calcitriol can be up to 7 days.
This is the 19th of 29 COVID-19 RCTs for vitamin D, which collectively show efficacy with p=0.0000024.
This is the 89th of 120 COVID-19 controlled studies for vitamin D, which collectively show efficacy with p<0.0000000001 (1 in 248 sextillion).
This study is excluded in the after exclusion results of meta analysis: randomization resulted in significant baseline differences that were not adjusted for.
risk of death, 79.2% lower, RR 0.21, p = 0.11, treatment 1 of 20 (5.0%), control 6 of 25 (24.0%), NNT 5.3.
risk of mechanical ventilation, 72.2% lower, RR 0.28, p = 0.08, treatment 2 of 20 (10.0%), control 9 of 25 (36.0%), NNT 3.8.
risk of ICU admission, 73.2% lower, RR 0.27, p = 0.006, treatment 3 of 20 (15.0%), control 14 of 25 (56.0%), NNT 2.4.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Zurita-Cruz et al., 25 Jul 2022, Single Blind Randomized Controlled Trial, Mexico, peer-reviewed, median age 12.0, 7 authors, study period 24 March, 2020 - 31 March, 2021, dosage 2,000IU daily, daily, 1,000IU for children <1 year, trial NCT04502667 (history). Contact: mirandaguadalupe2707@yahoo.com, guadalupe.mirandan@imss.gob.mx.
This PaperVitamin DAll
E cacy and safety of vitamin D supplementation in hospitalized COVID-pediatric patients: A randomized controlled trial
Maurizio Aricò, Mehmet Güven, Dr Rinawati Rohsiswatmo, Cipto Mangunkusumo, Guadalupe Miranda-Novales, Zurita-Cruz J Fonseca-Tenorio, Villasís-Keever M López-Alarcón, M Parra-Ortega I, López-Martínez, Jessie Zurita-Cruz, Je Ry Fonseca-Tenorio, Miguel Villasís-Keever, Mardia López-Alarcón, Israel Parra-Ortega, Briceida López-Martínez
Novales G ( ) E cacy and safety of vitamin D supplementation in hospitalized COVID-pediatric patients: A randomized controlled trial.
Ethics statement The studies involving human participants were reviewed and approved by Comité Local de Ética en Investigación number 3603, authorization number R-2020-3603-20. Written informed consent to participate in this study was provided by the participants' legal guardian/next of kin. Author contributions JZ-C, MV-K, ML-A, and GM-N: study design. JF-T, IP-O, BL-M, and GM-N: collection, analysis, and interpretation of data. JZ-C, GM-N, and MV-K: manuscript preparation and final approval. All the authors have contributed to the article and approved the submitted version of the manuscript. Conflict of interest The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. Publisher's note All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.
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{ 'DOI': '10.3389/fped.2022.943529', 'ISSN': ['2296-2360'], 'URL': 'http://dx.doi.org/10.3389/fped.2022.943529', '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>', 'alternative-id': ['10.3389/fped.2022.943529'], 'author': [ {'affiliation': [], 'family': 'Zurita-Cruz', 'given': 'Jessie', 'sequence': 'first'}, {'affiliation': [], 'family': 'Fonseca-Tenorio', 'given': 'Jeffry', 'sequence': 'additional'}, {'affiliation': [], 'family': 'Villasís-Keever', 'given': 'Miguel', 'sequence': 'additional'}, {'affiliation': [], 'family': 'López-Alarcón', 'given': 'Mardia', 'sequence': 'additional'}, {'affiliation': [], 'family': 'Parra-Ortega', 'given': 'Israel', 'sequence': 'additional'}, {'affiliation': [], 'family': 'López-Martínez', 'given': 'Briceida', 'sequence': 'additional'}, { 'affiliation': [], 'family': 'Miranda-Novales', 'given': 'Guadalupe', 'sequence': 'additional'}], 'container-title': 'Frontiers in Pediatrics', 'container-title-short': 'Front. Pediatr.', 'content-domain': {'crossmark-restriction': True, 'domain': ['frontiersin.org']}, 'created': {'date-parts': [[2022, 7, 25]], 'date-time': '2022-07-25T06:26:07Z', 'timestamp': 1658730367000}, 'deposited': { 'date-parts': [[2022, 7, 25]], 'date-time': '2022-07-25T06:26:11Z', 'timestamp': 1658730371000}, 'indexed': {'date-parts': [[2022, 7, 25]], 'date-time': '2022-07-25T06:42:20Z', 'timestamp': 1658731340098}, 'is-referenced-by-count': 0, 'issued': {'date-parts': [[2022, 7, 25]]}, 'license': [ { 'URL': 'https://creativecommons.org/licenses/by/4.0/', 'content-version': 'vor', 'delay-in-days': 0, 'start': { 'date-parts': [[2022, 7, 25]], 'date-time': '2022-07-25T00:00:00Z', 'timestamp': 1658707200000}}], 'link': [ { 'URL': 'https://www.frontiersin.org/articles/10.3389/fped.2022.943529/full', 'content-type': 'unspecified', 'content-version': 'vor', 'intended-application': 'similarity-checking'}], 'member': '1965', 'original-title': [], 'prefix': '10.3389', 'published': 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'doi-asserted-by': 'publisher', 'first-page': '1911', 'journal-title': 'J Clin Endocrinol Metabol.', 'key': 'B45', 'volume': '96', 'year': '2011'}, { 'DOI': '10.3389/fpubh.2022.888168', 'article-title': 'Vitamin D: a potential mitigation tool for the endemic stage of the ' 'COVID-19 pandemic?', 'author': 'Briceno Noriega', 'doi-asserted-by': 'publisher', 'journal-title': 'Front Public Health.', 'key': 'B46', 'volume': '10', 'year': '2022'}], 'reference-count': 46, 'references-count': 46, 'relation': {}, 'resource': {'primary': {'URL': 'https://www.frontiersin.org/articles/10.3389/fped.2022.943529/full'}}, 'score': 1, 'short-title': [], 'source': 'Crossref', 'subject': ['Pediatrics, Perinatology and Child Health'], 'subtitle': [], 'title': 'Efficacy and safety of vitamin D supplementation in hospitalized COVID-19 pediatric patients: A ' 'randomized controlled trial', 'type': 'journal-article', 'update-policy': 'http://dx.doi.org/10.3389/crossmark-policy', 'volume': '10'}
Late treatment
is less effective
Please send us corrections, updates, or comments. c19early involves the extraction of 100,000+ datapoints from thousands of papers. Community updates help ensure high accuracy. Treatments and other interventions are complementary. All practical, effective, and safe means should be used based on risk/benefit analysis. No treatment or intervention is 100% available and effective for all current and future variants. We do not provide medical advice. Before taking any medication, consult a qualified physician who can provide personalized advice and details of risks and benefits based on your medical history and situation. FLCCC and WCH provide treatment protocols.
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