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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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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. This study is excluded in the after exclusion results of meta analysis: combined treatments may contribute more to the effect seen.

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This study includes 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, this trial uses multiple treatments in the treatment arm (combined with comprehensive nutritional support) - results of individual treatments may vary, trial NCT04507867 (history).

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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

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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