A Randomized, Parallel-group Treatment, Quadruple Masked, Two-arm Study, to Assess the Effectiveness of Cod Liver Oil Compared to Placebo in the Prevention of Covid-19 and Airway Infections in Healthy Adults
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 47,210
- 试验地点
- 2
- 主要终点
- Number of participants diagnosed with New Covid-19
研究概览
简要总结
A randomized, parallel-group treatment, quadruple masked, two-arm study to assess the effectiveness of cod liver oil compared to placebo in the prevention of Covid-19 and airway infections in healthy adults.
In this study, the investigators will investigate whether daily cod liver oil can prevent Covid-19 infections and reduce the severity of such infections. The investigators will also examine whether cod liver oil prevents other airway infections in healthy adults.
详细描述
Preliminary evidence from literature and an ongoing study in the investigators' lab suggests that cod liver oil may prevent Covid-19 and complications of Covid-19. In the present study, the investigators will examine whether this is actually the case by randomizing volunteers to take cod liver oil or placebo (corn oil) during the winter months of 2020-2021. The investigators also aim to explore whether cod liver oil can prevent other respiratory tract infections, as well as explore and confirm already known health effects and possible new health effects, in particular rare adverse events associated with cod liver oil use.
Cod liver oil is a traditional source of vitamin A, D, and E and omega-3 fatty acids and the dose administered in the study will contain 250 ug vitamin A, 10 ug vitamin D, 10 mg vitamin E, and 1,2 g omega-3 fatty acids.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants, investigators, care providers, data collectors, outcomes assessors, and data analysts will be masked to the group assignment of each participant.
Unmasking will be done after analysis of all primary endpoints and, preferably, also all secondary endpoints are completed.
After unmasking the unmasked list will only be made available to study personnel needing this for conducting their tasks.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Any person >18 years with a Norwegian Personal Identity Number
排除标准
- •History of renal failure or dialysis, hypercalcemia, severe liver disease (cirrhosis), sarcoidosis or other granulomatous diseases (Wegener)
- •Allergy to fish or corn oil.
- •Pregnancy or planned pregnancy before summer 2021
- •Vegan diet
- •Age >75 years old at inclusion based on the Norwegian Personal Identity Number
- •Difficulty in swallowing cod liver oil or other oils
- •Previous Covid-19 disease
- •For Caucasians only: Use of any supplement containing more than trace amounts of vitamin D or omega-3 fatty acids at inclusion (Vitamin D levels in non-Caucasians living in Norway are frequently low even among those self-reporting using dietary supplements). This criterion will be relaxed if too few participants volunteer for the study and only Caucasians that use cod liver oil or an equivalent dietary supplement (with omega 3 and vitamin D) more than 5-7 times per week will be excluded.
结局指标
主要结局
Number of participants diagnosed with New Covid-19
时间窗: 6 months
The number of participants diagnosed with first time SARS-CoV-2 positive nasopharyngeal and or pharyngeal swabs (or any other sample used for detection of current disease) analyzed by reverse transcriptase quantitative polymerase chain reaction (RT-qPCR) nucleic acid amplification test or antigen tests used by accredited Norwegian microbiology laboratories from one week after the start of cod liver oil/placebo taking.
Number of participants diagnosed with serious Covid-19
时间窗: 6 months
The number of participants with first time SARS-CoV-2 positive nasopharyngeal and or pharyngeal swabs (or any other sample used for detection of current disease) analyzed by reverse transcriptase quantitative polymerase chain reaction (RT-qPCR) nucleic acid amplification test or antigen tests used by accredited Norwegian microbiology laboratories in the period from one week after the start of cod liver oil/placebo taking to the end of this period together with any of the following: A) Self-reported dyspnea and fever concurrent (within four weeks) with the positive test OR B) hospitalization caused by Covid-19 concurrent (within four weeks) with the positive test OR C) death where the Covid-19 infection was wholly or partly responsible as judged by the death certificate (see endpoint in the protocol)
Number of participants with self-reported airway infection
时间窗: 6 months
The number of episodes with any two of the following symptoms: fever, cough, nasal congestion or sore throat
Number of participants with negative SARS-CoV-2 test
时间窗: 6 months
Number of participants with an airway sample negative for SARS-CoV-2 (indicative of another airway infection). \*Influenza virus (A and B), parainfluenzavirus (1,2,3), metapneumovirus, rhinovirus, coronavirus (non-SARS), Respiratory Syncytial virus, Haemophilus Influenzae, Moraxella Catharralis, Streptococcus Pneumonia, Beta-hemolytic streptococci, Mycoplasma pneumonia, Chlamydophila pneumonia, Enterovirus, Bordetella pertussis. The list can be expanded based on the analyses performed in Norwegian Microbiology laboratories.
次要结局
- Number of visits at GP for infections(6 months)
- Number of participants hospitalized due to Covid-19(6 months)
- Number of participants with any admissions to hospital(6 months)
- Infection with each of the mentioned pathogens(6 months)
- Number of participants in Intensiv Care Unit (ICU) caused by Covid-19(6 months)
- Number of visits at GP(6 months)
研究者
Arne Vasli Lund Søraas
Principal Investigator, MD, PhD
Oslo University Hospital