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

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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

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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 174 items along with related searches
• Infant-Child category has 843 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

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Some other unethical Vitamin D trials

• Ethical challenge – giving vitamin D to only half of Cancer (etc) patients – Jan 2017
• Why many vitamin D trials fail to find benefits - Nov 2016 unethical is 1 of the 12 reasons
• Ensure a healthy pregnancy and infant with as little as $20 of Vitamin D Vitamin D has proven so successful that some researchers have decided that it is no longer ethical to not give vitamin D during every pregnancy.
• Vitamin D Random Controlled Trials are becoming impossible
• Is it ethical to not give vitamin D in osteoporosis trials– NEJM Sept 2010
• Proof that Vitamin D Works 93 proofs as of July 2022
  • In 16 of the proofs ( 21%) vitamin D was given to all participants in 2017
• Search Google Scholar for UNETHICAL "VITAMIN D" 4,400 items in Google Scholar as of July 2022

Unethical to not give to Children

• COVID children helped by Vitamin D, trial terminated: unethical to not give Vitamin D to all: – RCT July 2022
• Autism rate in siblings reduced 4X by vitamin D: 5,000 IU during pregnancy, 1,000 IU to infants – Feb 2016 vitamin D given to all, unethical otherwise
• Growing pains reduced 57 percent by vitamin D therapy – May 2015
  • vitamin D given to all, it was unethical otherwise
• Unethical to restrict Vitamin D to half of the asthmatic children in randomized controlled trial – June 2018

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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

• Number of people to treat to prevent 1 case of flu: Vitamin D 4, Vaccination 40 – Feb 2017
• NNT = 20 for premature birth
• Multiple Sclerosis: number needed to treat with vitamin D may be as low as 1.3 – Meta-analysis Oct 2013
• Google Scholar NNT "Vitamin D" 3,390 as of July 25, 2022
  • Vitamin D Status and SARS-CoV-2 Infection and COVID-19 Clinical Outcomes - Dec 2021 FREE PDF NNT = 8 for those with severe vitamin D deficiency