Clinical trial NCT05629975: Oral Nutritional Supplements in Treatment of Elderly Mild-to-Moderate COVID-19
Official title: Department of Thoracic Surgery, Shanghai Tongji Hospital, School of Medicine, Tongji University, Xincun Rd. 389, Shanghai, 200065, People's Republic of China.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nutrition, Healthy
Keywords: Oral nutritional supplements
Lead sponsor: Shanghai Tongji Hospital, Tongji University School of Medicine
Sponsor class: OTHER
First posted: 2022-11-29
Enrollment: 150
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: coagulation function and blood cell count (CBC)
timeFrame: 2 weeks
measure: kidney functions
timeFrame: 2 weeks
measure: ABG parameters
timeFrame: 2 weeks
measure: serum electrolytes
timeFrame: 2 weeks
measure: inflammatory indices
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Shanghai Tongji Hospital, Tongji University School of Medicine
name: Yongxin Zhou, Dr
role: STUDY_CHAIR
References: