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

Not Applicable

Not yet recruiting

• Conditions: Nutrition, Healthy
• Interventions: Dietary Supplement: Oral Nutritional Supplements

• Registration Number: NCT05629975
• Lead Sponsor: Shanghai Tongji Hospital, Tongji University School of Medicine

Brief Summary

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

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 Timeline

• Status Verified: 2022-11
• Study First Submitted: 2022-11-03
• Study First Submitted QC: 2022-11-23
• Last Update Submitted: 2022-11-23
• Study First Posted: 2022-11-29
• Last Update Posted: 2022-11-29
• Study Start: 2022-11-30
• Primary Completion: 2022-12-30
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Oral Nutritional Supplements	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.

Primary Outcome Measures

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