Department of Thoracic Surgery, Shanghai Tongji Hospital, School of Medicine, Tongji University, Xincun Rd. 389, Shanghai, 200065, People's Republic of China.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 主要终点
- serum electrolytes
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
serum electrolytes
时间窗: 2 weeks
potassium (K+)(mmol/L)
ABG parameters
时间窗: 2 weeks
oxygen partial pressure (PO2)(mmHg)
coagulation function and blood cell count (CBC)
时间窗: 2 weeks
white blood cell (WBC) count(\*109/L)
kidney functions
时间窗: 2 weeks
blood urea nitrogen (BUN)(mg/L)
inflammatory indices
时间窗: 2 weeks
interleukin-8 (IL-8)(pg/mL)
次要结局
未报告次要终点
研究者
Yongxin Zhou
Doctor
Shanghai Tongji Hospital, Tongji University School of Medicine