Authors
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Anahuac University -More
Category
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Primary study
Registry of Trials»clinicaltrials.gov
Year
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2020
The disease caused by SARS-CoV-2, has derived a pandemic in which its evolution and
complications depend on the immune capacity of the host. The virus has been characterized by
presenting an inflammatory cascade, increased by the overproduction of proinflammatory
cytokines, the decrease in metalloenzymes and also the rapid spread of the virus. There are
several lines of treatment, however, nutritional treatment only considered a caloric intake.
For this reason, this study will evaluate the evolution of patients with COVID-19 assisted by
nutritional support based on supplements such as omega 3, zinc, selenium, vitamin D,
glutamine, prebiotics, and foods such as spirulina and the effect of this therapy in reducing
complications and comorbidities. Research question: Will the nutritional support system
reduce complications in stage III positive COVID-19 patients with comorbidities (type 2 DM,
SAH, overweight / obesity with BMI <35), with a better benefit than that achieved with the
conventional nutritional treatment ?. Hypothesis: The nutritional support system will reduce
the complications of patients with COVID-19 in stage III with comorbidities. General
Objective: To determine the effect of the use of a nutritional support system on
complications in patients with COVID-19 in stage III with comorbidities. Methodology: A
controlled, blinded, randomized clinical trial will be conducted in patients with COVID-19,
hospitalized at the ISSEMYM Toluca Arturo Montiel Rojas Medical Center, who meet the
inclusion criteria. The evolution of the group of patients receiving the nutritional support
system (NSS) and the normal diet implemented by the hospital will be evaluated against the
group of patients receiving only the diet, using laboratory and cabinet tests during their
hospital stay. Statistical analysis: for independent groups with normal distribution,
Student\'s T will be applied. If the distribution does not meet normality criteria, a Mann
Whitney U will be performed; Two-way ANOVA will be applied to monitor the groups over time
with normal distribution. If the distribution does not meet normality criteria, a Friedman
test will be performed, in both cases post hoc tests will be performed. The results will be
analyzed using version 8 of the Graphpad Prism software.
Epistemonikos ID: e1be301b9f5b465f887f00bcf05e9c12d58ccfea
First added on: Aug 12, 2020