Effect of a special nutritional oral supplement use on inflammation in patients with COVID-19

Not Applicable

Recruiting

• Conditions: C23.550.470; Coronavirus Infections; Nutrition Therapy; Inflammation; C01.925.782.600.550.200; E02.642

• Registration Number: RBR-7jrxqm
• Lead Sponsor: niversidade do Estado da Bahia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-07-10
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Patients with the following criteria will be included: adults aged between 18 and 65 years, diagnosed with Covid-19 by molecular examination (RT-PCR), with pervious gastrointestinal tract, using oral diet and who are not on mechanical ventilation or requiring icu admission.

Exclusion Criteria

Pregnant patients; who have undergone the use of artificial nutrition in the 15 days prior to inclusion in this study; patients allergic to any components of the diets used; with severe hyperglycemia(greater than 180mg/dl) or hypertriglyceridemia (greater than 400mg/dl); with previous gastrointestinal diseases (surgical resections, malabsorption syndromes, inflammatory bowel diseases, persistent paralytic ileus, upper gastrointestinal bleeding or severe acute pancreatitis); with neutropenia-defined immunosuppression states, myelodysplastic syndromes, congenital immunodeficiency, or Acquired Immunodeficiency Syndrome (AIDS), immunosuppressive therapies in the last 03 months, systemic chemotherapy in the last 03 months, autologous bone marrow transplantation in the last year, halogenic bone marrow transplantation in the last 02 years, or existence of graft versus host disease (DEVH); with advanced chronic diseases (Child-Pugh stage C, grade IV heart failure (NYHA), chronic functional stage lung failure IV, terminal degenerative neurological processes, neoplasms in remission or progression over treatment); with processes with short life expectancy including end-stage chronic kidney disease; with acute processes that determine small survival as shock of any etiology with multiple organ dysfunction refractory to therapy in the first 48h or post-resuscitation severe neurological damage within 72 hours will be excluded

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
We will observe the reduction of serum levels of inflammatory markers (C-Reactive Protein, IL6 and TNF-) in patients infected with Covid-19 through serum biochemical dosage from the finding of at least 30% difference between groups.

Secondary Outcome Measures

Name	Time	Method
We will estimate the incidence of Acute Respiratory Distress Syndrome among Covid-19-infected patients who receive standard hyperprotein or immunonutrient-enriched normocalic supplementation through a questionnaire or medical records.;We will estimate length of hospital stay of patients infected with Covid-19 who receive standard hyperprotein or immunonutrient-enriched normalcalic supplementation through a questionnaire or medical records.;We will evaluate the nutritional risk and status of the patients included through anthropometric data measurement and application of the Nutritional Risk Screening 2002 Tool.