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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.

Lower risk for mortality, ICU admission, hospitalization, progression, recovery, cases, and viral clearance.

No treatment is 100% effective. Protocols combine complementary and synergistic treatments. ^* >10% efficacy in meta analysis with ≥3 clinical studies.

4,000+ 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.

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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 Paper Vitamin D All

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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Late treatment
is less effective

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