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Cod Liver Oil for Covid-19 Prevention Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04609423
Recruitment Status : Recruiting
First Posted : October 30, 2020
Last Update Posted : November 12, 2020
Sponsor:
Collaborators:
University of Oslo
Norwegian Institute of Public Health
Information provided by (Responsible Party):
Arne Vasli Lund Søraas, Oslo University Hospital

Brief 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.


Condition or disease Intervention/treatment Phase
Covid-19 Respiratory Tract Infections Dietary Supplement: Cod liver oil Dietary Supplement: Corn oil (placebo) Phase 4

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A parallel-group treatment, two-arm study where participants are randomly assigned to cod liver oil or placebo (corn oil) in a 1:1 ratio
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:

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.

Primary Purpose: Prevention
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
Actual Study Start Date : November 10, 2020
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cod liver oil
supplementation for 6 months
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.
Other Names:
  • 10 ug of vitamin D and 1 g n-3 LCPUFA
  • Tran

Placebo Comparator: Corn oil (placebo)
supplementation for 6 months
Dietary Supplement: 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




Primary Outcome Measures :
  1. Number of participants diagnosed with serious Covid-19 [ Time Frame: 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)


  2. Number of participants diagnosed with New Covid-19 [ Time Frame: 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.

  3. Number of participants with laboratory confirmed respiratory tract infection [ Time Frame: 6 months ]

    Number of participants with 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.


  4. Number of participants with self-reported airway infection [ Time Frame: 6 months ]
    The number of episodes with any two of the following symptoms: fever, cough, nasal congestion or sore throat


Secondary Outcome Measures :
  1. Number of participants hospitalized due to Covid-19 [ Time Frame: 6 months ]
    Number of participants hospitalized wholly or partly caused by Covid-19.

  2. Number of participants in Intensiv Care Unit (ICU) caused by Covid-19 [ Time Frame: 6 months ]
    Number of participants with ICU care wholly or partly caused by Covid-19.

  3. Number of participants with any admissions to hospital [ Time Frame: 6 months ]
    Number of participants with any admissions to hospital based on the Norwegian Patient Registry data.

  4. Infection with each of the mentioned pathogens [ Time Frame: 6 months ]

    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.


  5. Number of visits at GP for infections [ Time Frame: 6 months ]
    Based on The Norwegian Reimbursement Database

  6. Number of visits at GP [ Time Frame: 6 months ]
    Based on The Norwegian Reimbursement Database


Other Outcome Measures:
  1. Incidence of Cardiovascular disease [ Time Frame: 6 months ]
    Based on self-reporting and Norwegian Registries

  2. Incidence of Cardiovascular disease [ Time Frame: 30 months ]
    Based on self-reporting and Norwegian Registries

  3. Incidence of cardiovascular mortality [ Time Frame: 6 months ]
    Based on self-reporting and Norwegian Registries

  4. Incidence of cardiovascular mortality [ Time Frame: 30 months ]
    Based on self-reporting and Norwegian Registries

  5. Incidence of cancer [ Time Frame: 6 months ]
    Based on self-reporting and Norwegian Registries

  6. Incidence of cancer [ Time Frame: 30 months ]
    Based on self-reporting and Norwegian Registries

  7. Incidence of cancer mortality [ Time Frame: 6 months ]
    Based on self-reporting and Norwegian Registries

  8. Incidence of cancer mortality [ Time Frame: 30 months ]
    Based on self-reporting and Norwegian Registries

  9. All-cause mortality [ Time Frame: 6 months ]
    Based on self-reporting and Norwegian Registries

  10. All-cause mortality [ Time Frame: 30 months ]
    Based on self-reporting and Norwegian Registries

  11. Incidence of fracture of the hip or forearm [ Time Frame: 6 months ]
    Based on self-reporting and Norwegian Registries

  12. Incidence of fracture of the hip or forearm [ Time Frame: 30 months ]
    Based on self-reporting and Norwegian Registries

  13. Incident dementia [ Time Frame: 6 months ]
    Based on self-reporting and Norwegian Registries

  14. Incident dementia [ Time Frame: 30 months ]
    Based on self-reporting and Norwegian Registries

  15. Number of participants diagnosed with serious Covid-19 [ Time Frame: 12 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)


  16. Number of participants diagnosed with new Covid-19 [ Time Frame: 12 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.

  17. Laboratory confirmed respiratory tract infection [ Time Frame: 12 months ]

    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.


  18. Self-reported airway infection [ Time Frame: 12 months ]
    The number of episodes with any two of the following symptoms: fever, cough, nasal congestion or sore throat

  19. Number of participants with self-reported cod liver oil related adverse events [ Time Frame: 12 months ]
    Number of participants with self-reported adverse events

  20. Number of participants with cod liver oil related adverse events [ Time Frame: 12 months ]
    Number of participants hospitalized for major diseases or death in the cod liver oil versus placebo group in Norwegian registries



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04609423


Contacts
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Contact: Arne Søraas, MD, PhD +4790652904 arvsoe@ous-hf.no
Contact: John Arne Dahl, PhD +4741456596 j.a.dahl@medisin.uio.no

Locations
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Norway
Oslo University Hospital Recruiting
Oslo, Norway, 0424
Contact: Arne Søraas, MD, PhD    +47 90652904    arvsoe@ous-hf.no   
Contact: John Arne Dahl, PhD    +4741456596    j.a.dahl@medisin.uio.no   
Sub-Investigator: Merete Ellingjord-Dale, PhD         
Sponsors and Collaborators
Oslo University Hospital
University of Oslo
Norwegian Institute of Public Health
Investigators
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Principal Investigator: Arne Søraas, MD, PhD Oslo University Hospital
  Study Documents (Full-Text)

Documents provided by Arne Vasli Lund Søraas, Oslo University Hospital:
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Responsible Party: Arne Vasli Lund Søraas, Principal Investigator, MD, PhD, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT04609423    
Other Study ID Numbers: REK-172796
First Posted: October 30, 2020    Key Record Dates
Last Update Posted: November 12, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD is complicated to share under the European General Data Protection Regulative, however, it is an aim of the study to make such data available within these regulations.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Arne Vasli Lund Søraas, Oslo University Hospital:
Cod liver oil
Vitamin D
n-3 LCPUFAs
SARS-CoV virus
Additional relevant MeSH terms:
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Infection
Respiratory Tract Infections
Respiratory Tract Diseases
Vitamin D
Cod Liver Oil
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents