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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Department of Thoracic Surgery, Shanghai Tongji Hospital, School of Medicine, Tongji University, Xincun Rd. 389, Shanghai, 200065, People's Republic of China.

Conditions
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Nutrition, Healthy

Intervention / Treatment
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* Dietary Supplement: Oral Nutritional Supplements


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

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>In addition to the normal diet in the hospital, patients in the intervention group received a package of nutritional powder in the morning and evening of every day, and each package was diluted with 500 ml of water. 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. | Dietary Supplement: Oral Nutritional Supplements<br>* 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.<br>|
| No Intervention: Control group<br>Patients in the control group received normal diet provided by the hospital. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| coagulation function and blood cell count (CBC) | white blood cell (WBC) count(*109/L) | 2 weeks | 
| kidney functions | blood urea nitrogen (BUN)(mg/L) | 2 weeks | 
| ABG parameters | oxygen partial pressure (PO2)(mmHg) | 2 weeks | 
| serum electrolytes | potassium (K+)(mmol/L) | 2 weeks | 
| inflammatory indices | interleukin-8 (IL-8)(pg/mL) | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oral nutritional supplements