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.,
Effect of a Nutritional Support System to Increase Survival and Reduce Mortality in Patients with COVID-19 in..,
International Journal of Environmental Research and Public Health, doi:10.3390/ijerph19031172 (date from earlier preprint), NCT04507867
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.
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.
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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.
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Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
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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).
Abstract: International Journal of
Environmental Research
and Public Health
Article
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 1, *, Lorena Abarca-Bernal 1 , Alejandra García-Pérez 1 , Dinnaru González-Tolosa 1 ,
Georgina Cruz-Cázares 1 , Marco Montell-García 2 and Antonio Ibarra 1
1
2
*
Citation: Leal-Martínez, F.;
Abarca-Bernal, L.; García-Pérez, A.;
González-Tolosa, D.; Cruz-Cázares,
G.; Montell-García, M.; Ibarra, A.
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.
Int. J. Environ. Res. Public Health 2022,
19, 1172. https://doi.org/10.3390/
Centro de Investigación en Ciencias de la Salud (CICSA), Facultad de Ciencias de la Salud (FCS),
Universidad Anáhuac México Norte, Mexico City 52786, Mexico; lore19.ab@gmail.com (L.A.-B.);
alejandragp_@hotmail.com (A.G.-P.); din.tolosa@gmail.com (D.G.-T.);
georgina.crucaz@hotmail.com (G.C.-C.); jose.ibarra@anahuac.mx (A.I.)
Centro Médico ISSEMyM (CMI) Toluca “Lic. Arturo Montiel Rojas”, Toluca City 52170, Mexico;
cazabichos@yahoo.com
Correspondence: ferman5@hotmail.com; Tel.: +52-5521094339
Abstract: 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.
ijerph19031172
Academic Editor: Paul B. Tchounwou
Keywords: COVID-19; SARS-CoV-2; nutritional support; NSS; nutrition; supplementation; probiotics;
pneumonia; survival; mortality
Received: 13 November 2021
Accepted: 31 December 2021
Published: 21 January 2022
Publisher’s Note: MDPI stays neutral
Late treatment
is less effective
lealmartinez
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