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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05629975

Acronym

ONSITEMC

Enrollment

150

Registered

2022-11-29

Start date

2022-11-30

Completion date

2022-12-31

Last updated

2022-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nutrition, Healthy

Keywords

Oral nutritional supplements

Brief summary

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).

Interventions

DIETARY_SUPPLEMENTOral 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

60 Years to 90 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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)
ABG parameters	2 weeks	oxygen partial pressure (PO2)(mmHg)
serum electrolytes	2 weeks	potassium (K+)(mmol/L)
inflammatory indices	2 weeks	interleukin-8 (IL-8)(pg/mL)

Contacts

Primary ContactWenli Wang, Dr

anderson840913@163.com13761295864

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026