Cod Liver Oil for Covid-19 Prevention Study

Covid-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04609423
• Other study ID #: REK-172796
• Status: Completed
• Phase: Phase 4
• Start date: November 10, 2020
• Est. completion date: June 2, 2021

Study information

• Verified date: March 2022
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47210
• Est. completion date: June 2, 2021
• Est. primary completion date: June 2, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Any person >18 years with a Norwegian Personal Identity Number

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Covid-19
• Infections
• Respiratory Tract Infections

Intervention

Dietary Supplement:
• Cod liver oil
5 ml of cod liver oil as a source of 10 ug of vitamin D and 1.2 g of long-chained n-3 polyunsaturated fatty acids (DHA 0,6g and EPA 0,4g) per day for 6 months x 1 time/day together with the first meal of the day. 5ml of Cod liver oil also contains 250ug vitamin A and 10 mg vitamin E.
• Corn oil (placebo)
5 ml of corn oil per day for 6 months x 1 time/day together with the first meal of the day

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (3)

Lead Sponsor	Collaborator
Oslo University Hospital	Norwegian Institute of Public Health, University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of Cardiovascular disease	Based on self-reporting and Norwegian Registries	6 months
Other	Incidence of Cardiovascular disease	Based on self-reporting and Norwegian Registries	30 months
Other	Incidence of cardiovascular mortality	Based on self-reporting and Norwegian Registries	6 months
Other	Incidence of cardiovascular mortality	Based on self-reporting and Norwegian Registries	30 months
Other	Incidence of cancer	Based on self-reporting and Norwegian Registries	6 months
Other	Incidence of cancer	Based on self-reporting and Norwegian Registries	30 months
Other	Incidence of cancer mortality	Based on self-reporting and Norwegian Registries	6 months
Other	Incidence of cancer mortality	Based on self-reporting and Norwegian Registries	30 months
Other	All-cause mortality	Based on self-reporting and Norwegian Registries	6 months
Other	All-cause mortality	Based on self-reporting and Norwegian Registries	30 months
Other	Incidence of fracture of the hip or forearm	Based on self-reporting and Norwegian Registries	6 months
Other	Incidence of fracture of the hip or forearm	Based on self-reporting and Norwegian Registries	30 months
Other	Incident dementia	Based on self-reporting and Norwegian Registries	6 months
Other	Incident dementia	Based on self-reporting and Norwegian Registries	30 months
Other	Number of participants diagnosed with serious Covid-19	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)	12 months
Other	Number of participants diagnosed with new Covid-19	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.	12 months
Other	Laboratory confirmed respiratory tract infection	An airway sample positive for a respiratory pathogen* (either PCR or culture).; *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.	12 months
Other	Self-reported airway infection	The number of episodes with any two of the following symptoms: fever, cough, nasal congestion or sore throat	12 months
Other	Number of participants with self-reported cod liver oil related adverse events	Number of participants with self-reported adverse events	12 months
Other	Number of participants with cod liver oil related adverse events	Number of participants hospitalized for major diseases or death in the cod liver oil versus placebo group in Norwegian registries	12 months
Primary	Number of participants diagnosed with serious Covid-19	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)	6 months
Primary	Number of participants diagnosed with New Covid-19	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.	6 months
Primary	Number of participants with negative SARS-CoV-2 test	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.	6 months
Primary	Number of participants with self-reported airway infection	The number of episodes with any two of the following symptoms: fever, cough, nasal congestion or sore throat	6 months
Secondary	Number of participants hospitalized due to Covid-19	Number of participants hospitalized wholly or partly caused by Covid-19.	6 months
Secondary	Number of participants in Intensiv Care Unit (ICU) caused by Covid-19	Number of participants with ICU care wholly or partly caused by Covid-19.	6 months
Secondary	Number of participants with any admissions to hospital	Number of participants with any admissions to hospital based on the Norwegian Patient Registry data.	6 months
Secondary	Infection with each of the mentioned pathogens	An airway sample positive for a respiratory pathogen* (either PCR or culture) in the period from one week after the start of cod liver oil/placebo taking to the end of this period.; *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.	6 months
Secondary	Number of visits at GP for infections	Based on The Norwegian Reimbursement Database	6 months
Secondary	Number of visits at GP	Based on The Norwegian Reimbursement Database	6 months