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COVID children helped by Vitamin D, trial terminated: unethical to not give Vitamin D to all: – RCT July 2022

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

Front. Pediatr., 25 July 2022 Sec. Pediatric Infectious Diseases https://doi.org/10.3389/fped.2022.943529
Jessie Zurita-Cruz1, Jeffry Fonseca-Tenorio2, Miguel Villasís-Keever3, Mardia López-Alarcón4, Israel Parra-Ortega5, Briceida López-Martínez6 and Guadalupe Miranda-Novales3*
1 Faculty of Medicine, National Autonomous University of Mexico, Pediatric Hospital Federico Gómez, Mexico City, Mexico
2 Infectious Diseases Department, Pediatric Hospital National Medical Center, XXI Century, Mexican Institute of Social Security, Mexico City, Mexico
3 Analysis and Synthesis of the Evidence Research Unit, National Medical Center XXI Century, Mexican Institute of Social Security, Mexico City, Mexico
4 Medical Nutrition Research Unit, Pediatric Hospital National Medical Center, XXI Century, Mexican Institute of Social Security, Mexico City, Mexico
5 Clinical Laboratory Department, Hospital Infantil de México Federico Gómez, Mexico City, Mexico
6 Auxiliary Diagnostic Services, Hospital Infantil de México Federico Gómez, Ministry of Health, Mexico City, Mexico

C-reactive Protein (inflammation) dropped to nearly zero in 7 days

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.
 Download the PDF from VitaminDWiki

Suggest: Better results if had uses more vs age/weight

  • It had used 1,000 IU for < age 1 and only 2,000 IU for ages 1-17
  • Suggested dosing:
    • ages 0-0.5 1,000 IU
    • ages 0.5-2 2,000 IU
    • ages 3-5 3,000 IU
    • ages 6-17 5,000 IU
  • Youth category has 172 items along with related searches
  • Infant-Child category has 817 items along with related searches
  • Suggest a Gut-Friendly Vitamin D given to all children
  • Suggest even more given to children who had <10 ng
  • Suggest a loading dose to get vitamin D levels raised as soon as possible

Some other unethical Vitamin D trials

Unethical to not give to Children

Number needed to treat (how many to be dosed to change outcome for one person)

for this low dose study: NNT = 3 to prevent progression

Created by admin. Last Modification: Monday December 5, 2022 16:29:12 GMT-0000 by admin. (Version 16)

Attached files

ID Name Comment Uploaded Size Downloads
18179 C-reactive.jpg admin 25 Jul, 2022 14.82 Kb 348
18178 COVID children and vit D RCT_CompressPdf.pdf admin 25 Jul, 2022 228.71 Kb 248