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

• Register: REBEC
• Last refreshed on: 29 May 2023
• Main ID: RBR-7jrxqm
• Date of registration: 10/07/2020
• Prospective Registration: No
• Primary sponsor: Universidade do Estado da Bahia
• Public title: Effect of a special nutritional oral supplement use on inflammation in patients with COVID-19
• Scientific title: Effect of oral supplement use with immunonutrients on inflammatory response in patients with COVID-19
• Date of first enrolment: 01/06/2020
• Recruitment status: Recruiting
• URL: http://ensaiosclinicos.gov.br/rg/RBR-7jrxqm
• Study type: Intervention
• Study design: Randomized, double-blind, parallel, two-arm treatment trial
• Phase: N/A

Countries of recruitment

Brazil

Contacts

• Name: Rodrigo Fernandes Weyll Pimentel
• Affiliation: Complexo Hospitalar Professor Edgard Santos

• Name: RODRIGO WEYLL PIMENTEL
• Affiliation: UNIVERSIDADE DO ESTADO DA BAHIA

Key inclusion & exclusion criteria

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

Age minimum: 18Y
Age maximum: 65Y
Gender: -

Health Condition(s) or Problem(s) studied

C01.925.782.600.550.200

E02.642

C23.550.470

Coronavirus Infections; Nutrition Therapy; Inflammation

Intervention(s)

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

Dietary supplement

G07.203.300.456

Primary Outcome(s)

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(s)

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.

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.

Source(s) of Monetary Support

Universidade do Estado da Bahia

Secondary Sponsor(s)

Universidade do Estado da Bahia