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

Authors
Category Primary study
Registry of TrialsBrazilian Registry of Clinical Trials
Year 2020
INTERVENTION: Dietary supplement Dietary Supplements Fifty patients will be randomized to receive either standard hyperprotein normcaloric supplement (control ‐ 25 participants) or immunonutrient‐enriched supplement (experiment ‐ 25 participants) at a ratio of 1:1 for a period of 07 days. Supplements will be blinded to patients. Researchers will not know which supplement each patient will use until the end of the study. The control supplement will provide, for every 100ml, 120kcal, 6.5g of protein, without adding any immunonutrition component (Nutren Senior®, Nestlé). The immunomodulatory supplement will offer, every 100ml, 109kcal, 6.5g of protein, with the addition of L‐arginine, nucleotides and fatty acids omega‐3 (Impact®, Nestlé). Both will receive 200ml of supplementation daily. Administration of the supplement will occur 02 times a day, initiated immediately after inclusion of the patient in the study, and will be maintained for 07 days. The drug treatment of the underlying pathology will follow the institutional protocol CONDITION: A00‐B99 Coronavirus Infections Coronavirus Infections; Nutrition Therapy; Inflammation ; Coronavirus Infections ; Nutrition Therapy ; Inflammation Inflammation Nutrition Therapy PRIMARY OUTCOME: 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: 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 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 evaluate the nutritional risk and status of the patients included through anthropometric data measurement and application of the Nutritional Risk Screening 2002 Tool. 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.
Epistemonikos ID: d76d1ae6e875eb3b48d7950c65da5c1dcc0eb089
First added on: Jul 15, 2020