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

NCT ID: NCT05629975

Last Updated: 2022-11-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-30
• Study Completion Date: 2022-12-31

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).

Conditions

Nutrition, Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Intervention group

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.

Group Type: EXPERIMENTAL

Oral Nutritional Supplements

Intervention Type: DIETARY_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.

Control group

Patients in the control group received normal diet provided by the hospital.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Oral Nutritional Supplements

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Tongji Hospital, Tongji University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Yongxin Zhou

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yongxin Zhou, Dr

Role: STUDY_CHAIR

Shanghai Tongji Hospital, Tongji University School of Medicine

Central Contacts

Wenli Wang, Dr

Role: CONTACT

anderson840913@163.com

13761295864

Other Identifiers

SBKT-2022-201

Identifier Type: -

Identifier Source: org_study_id