The Effect of Vitamin A Supplementation on Disease Improvement of Children With Moderate to Severe COVID-19.
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 主要终点
- 28-day mortality rate
研究概览
简要总结
Severe acute respiratory syndrome (SARS)-like coronavirus 2 (Sars-CoV-2) pandemia is considered to be the current major global health issue. With no specific treatment or vaccine known to be licensed, empowering the immune system to overcome the inflammatory status associated with the late stages of the disease, particularly by anti-inflammatory nutrients, is of great concern.
Effective in reducing both the morbidity and mortality of respiratory infections, including measles, vitamin A and its derivatives are reported to enhance the immune system and/or antibody response to virus vaccinations in children, particularly those with vitamin insufficiency. Retinoids are, therefore, proposed as an adjunct therapy in the treatment of COVID-19. The study is aimed to investigate the effects of vitamin A supplementation on disease improvement in pediatric and adolescent patients with either moderate or severe COVID-19 disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
Participants, laboratory technicians, and statisticians will be blinded to the study arm allocation. Investigators and the ICU medical staff, however, will be unblinded due to the nature of intervention.
入排标准
- 年龄范围
- 1 Month 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged between 1-month to 18-year old (boy or girl), 2) definitive or clinical diagnosis of severe acute respiratory syndrome (SARS)-like coronavirus 2 (SARS-COV-2) infection (by either a positive SARS-COV-2 polymerase chain reaction (PCR) test or a suggestive computed tomography (CT) scan, 3) no history or evidence of cancer or renal, hepatic, endocrine or viral disorders (including HIV/AIDS), 4) no history of supplementation either with vitamin A (VA) or with a multivitamin containing VA within the last 4 months, and 5) not participated in other clinical trials.
排除标准
- •mildly infected with SARS-COV-2 virus, and 2) pregnancy or lactation.
结局指标
主要结局
28-day mortality rate
时间窗: within 28 days from end of intervention
COVID-19 mortality rate is defined as the number of deaths per 100 pediatric COVID-19 cases 28 days from the date of the intervention.
次要结局
- Partial thromboplastin time (PTT)(before and within 3 days from end of intervention)
- Alanine transaminase (ALT)(before and within 3 days from end of intervention)
- Cr(before and within 3 days from end of intervention)
- C-reactive protein (CRP)(before and within 3 days from end of intervention)
- Prothrombin time (PT)(before and within 3 days from end of intervention)
- Aspartate transaminase (AST)(before and within 3 days from end of intervention)
- ferritin(before and within 3 days from end of intervention)
- vitamin A concentration(before and within 3 days from end of intervention)
- length of hospital stay(on the day of hospital discharge)
- length of intubation(on the day of extubation)
- length of mechanical ventilation(the weaning time of mechanical ventilation)
- Lactate dehydrogenase (LDH)(before and within 3 days from end of intervention)
- procalcitonin(before and within 3 days from end of intervention)
- fibrinogen(before and within 3 days from end of intervention)
- length of pediatric intensive care unit (PICU) stay(on the day of PICU discharge)
- multiple organ involvement(on the day of the particular organ involvement)
- complete blood count (CBC)/diff(before and within 3 days from end of intervention)
- International normalised ratio (INR)(before and within 3 days from end of intervention)
- troponin(before and within 3 days from end of intervention)
- Blood urea nitrogen (BUN)(before and within 3 days from end of intervention)
- D-dimer(before and within 3 days from end of intervention)
- Erythrocyte sedimentation rate (ESR)(before and within 3 days from end of intervention)
研究者
Seyede Sedigheh Hamzavi
Assistant Professor
Shiraz University of Medical Sciences