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Effect of a Nutritional Support System to Increase Survival and Reduce Mortality in Patients with COVID-19 in Stage III and Comorbidities: A Blinded Randomized Controlled Clinical Trial

Leal-Martínez et al., International Journal of Environmental Research and Public Health, doi:10.3390/ijerph19031172 (date from preprint), NCT04507867
Oct 2021  
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Mortality 86% Improvement Relative Risk Ventilation 57% Vitamin D  Leal-Martínez et al.  LATE TREATMENT  RCT Is late treatment with vitamin D + combined treatments beneficial for COVID-19? RCT 80 patients in Mexico (September 2020 - February 2021) Lower mortality with vitamin D + combined treatments (p=0.027) Combined treatments may contribute more to the effect seen c19early.org Leal-Martínez et al., Int. J. Environm.., Oct 2021 Favorsvitamin D Favorscontrol 0 0.5 1 1.5 2+
Vitamin D for COVID-19
8th treatment shown to reduce risk in October 2020, now with p < 0.00000000001 from 122 studies, recognized in 9 countries.
No treatment is 100% effective. Protocols combine treatments.
5,100+ studies for 112 treatments. c19early.org
80 patient RCT with 40 patients treated with a comprehensive regimen of nutritional support, showing significantly lower mortality with treatment. Treatment contained cholecalciferol, vitamin C, zinc, spirulina maxima, folic acid, glutamine, vegetable protein, selenium, resveratrol, omega-3 fatty acids, l-arginine, magnesium, probiotics, and B-complex IV. Adherence was strictly monitored.
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: 69% [47‑82%] lower risk vs. 39% [27‑49%] 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 8th of 30 COVID-19 RCTs for vitamin D, which collectively show efficacy with p=0.0000032.
This is the 57th of 122 COVID-19 controlled studies for vitamin D, which collectively show efficacy with p<0.0000000001 (1 in 587 sextillion).
This study is excluded in the after exclusion results of meta analysis: combined treatments may contribute more to the effect seen.
Study covers vitamin B9, vitamin D, probiotics, zinc, and vitamin C.
risk of death, 85.7% lower, RR 0.14, p = 0.03, treatment 1 of 40 (2.5%), control 7 of 40 (17.5%), NNT 6.7.
risk of mechanical ventilation, 57.1% lower, RR 0.43, p = 0.31, treatment 3 of 40 (7.5%), control 7 of 40 (17.5%), NNT 10.0.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Leal-Martínez et al., 25 Oct 2021, Randomized Controlled Trial, Mexico, peer-reviewed, 7 authors, study period 1 September, 2020 - 28 February, 2021, dosage 4,000IU days 1-21, this trial uses multiple treatments in the treatment arm (combined with comprehensive nutritional support) - results of individual treatments may vary, trial NCT04507867 (history).
This PaperVitamin DAll
Effect of a Nutritional Support System to Increase Survival and Reduce Mortality in Patients with COVID-19 in Stage III and Comorbidities: A Blinded Randomized Controlled Clinical Trial
Fernando Leal-Martínez, Lorena Abarca-Bernal, Alejandra García-Pérez, Dinnaru González-Tolosa, Georgina Cruz-Cázares, Marco Montell-García, Antonio Ibarra
International Journal of Environmental Research and Public Health, doi:10.3390/ijerph19031172
The COVID-19 evolution depends on immunological capacity. The global hospital mortality rate is 15-20%, but in México it is 46%. There are several therapeutic protocols, however, integral nutrition is not considered. In this study, a Nutritional Support System (NSS) was employed to increase survival and reduce mortality in patients with stage III COVID-19. A randomized, blinded, controlled clinical trial was performed. Eighty patients (aged 30 to 75 years, both sexes) were assigned to (1) "Control Group" (CG) hospital diet and medical treatment or (2) "Intervention Group" (IG) hospital diet, medical treatment, and the NSS (vitamins, minerals, fiber, omega-3, amino acids, Bcomplex, and probiotics). IG significantly increased survival and reduced mortality compared to CG (p = 0.027). IG decreased progression to Mechanical Ventilation Assistance (MVA) by 10%, reduced the intubation period by 15 days, and increased survival in intubated patients by 38% compared to CG. IG showed improvement compared to CG in decrease in supplemental oxygen (p = 0.014), the qSOFA test (p = 0.040), constipation (p = 0.014), the PHQ-9 test (p = 0.003), and in the follow-up, saturation with oxygen (p = 0.030). The NSS increases survival and decreases mortality in patients with stage III COVID-19.
Conflicts of Interest: The authors declare that they have no conflict of interest.
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Late treatment
is less effective
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