Oral Nutritional Supplements in Treatment of Elderly Mild-to-Moderate COVID-19

Shanghai Tongji Hospital, Tongji University School of Medicine150 enrolled

Overview

The coronavirus disease 2019 (COVID-19) pandemic has seriously threatened public health worldwide. Nutritional supplements may have a positive influence on the recovery of patients with viral infection. This study aimed to assess the influence of oral nutritional supplements (ONSs) on the biochemical parameters of elderly patients with mild-to-moderate COVID-19. This clinical trial will be conducted on 145 elderly patients with mild-to-moderate COVID-19. Patients in the intervention group (n=74) received nutritional powder (vitamins, minerals, dietary fiber, polyphenols, omega-3, amino acids, and probiotics) for 14 days. Cases in the control group (n=71) took the placebo, except for nutritional powder, and they received the same treatment. Biochemical parameters were measured before and two weeks after intervention. After 14 days, patients in the groups will be measured by C-reactive protein (CRP), creatinine (Cr), blood urea nitrogen (BUN), and interleukin-8 (IL-8) ,white blood cell (WBC), red blood cell (RBC), platelet (PLT), neutrophil percentage (NE%), prothrombin time (PT), D-Dimer (DD), blood glucose, sodium (Na+), potassium (K+), aspartate aminotransferase (AST), glutamate pyruvic transaminase (ALT), albumin, calcium (Ca), arterial blood gas (ABG) parameters, and interleukin-10 (IL-10).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Interventions

Oral Nutritional SupplementsDIETARY_SUPPLEMENT

Each package contained L-arginine (750 mg), methionine (300 mg), glutamine (5 g), plant protein (10 g), vitamin B12 (1 ug), vitamin C (50 mg), vitamin D (2000 IU), vitamin A (300 mg), folic acid (5 mg), omega-3 fatty acid (1 g), zinc (20 mg), magnesium (400 mg), selenium (100 mcg), whole wheat fiber (5 g), carotenoid (3 mg), curcumin supplement (500 mg). Probiotics included orally administration of clostridium butyricum\& bifidobacterium (500 mg) every day for 7 days.

Eligibility

Sex: ALLMin age: 60 YearsMax age: 90 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. COVID-19-positive was confirmed by reverse transcription-polymerase chain reaction (RT-PCR); 2. Mild-to-moderate COVID-19 patients who aged 60-90 years old; 3. Consistency with the indication of enteral nutrition; 4. The time from diagnosis of COVID-19 to hospitalization was less than 24 h. Exclusion Criteria: 1. Oxygen saturation \< 93% or mechanical ventilation was required; 2. Systemic diseases (malignant tumors, autoimmune diseases, liver or kidney diseases); 3. Participation in other clinical trials within 3 months; 4. History of allergy to nutrients in the trial.

Outcomes

Primary Outcomes

coagulation function and blood cell count (CBC)

white blood cell (WBC) count(\*109/L)

Time frame: 2 weeks

kidney functions

blood urea nitrogen (BUN)(mg/L)

Time frame: 2 weeks

ABG parameters

oxygen partial pressure (PO2)(mmHg)

Time frame: 2 weeks

serum electrolytes

potassium (K+)(mmol/L)

Time frame: 2 weeks

inflammatory indices

interleukin-8 (IL-8)(pg/mL)

Time frame: 2 weeks

Oral Nutritional Supplements in Treatment of Elderly Mild-to-Moderate COVID-19

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Central Contacts