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Cod Liver Oil for Covid-19 Prevention Study

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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

Tracking Information
First Submitted Date  ICMJE October 22, 2020
First Posted Date  ICMJE October 30, 2020
Last Update Posted Date November 12, 2020
Actual Study Start Date  ICMJE November 10, 2020
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 28, 2020)
  • 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)
  • 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.
  • 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.
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 28, 2020)
  • Number of participants hospitalized due to Covid-19 [ Time Frame: 6 months ]
    Number of participants hospitalized wholly or partly caused by Covid-19.
  • 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.
  • 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.
  • 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.
  • Number of visits at GP for infections [ Time Frame: 6 months ]
    Based on The Norwegian Reimbursement Database
  • Number of visits at GP [ Time Frame: 6 months ]
    Based on The Norwegian Reimbursement Database
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 29, 2020)
  • Incidence of Cardiovascular disease [ Time Frame: 6 months ]
    Based on self-reporting and Norwegian Registries
  • Incidence of Cardiovascular disease [ Time Frame: 30 months ]
    Based on self-reporting and Norwegian Registries
  • Incidence of cardiovascular mortality [ Time Frame: 6 months ]
    Based on self-reporting and Norwegian Registries
  • Incidence of cardiovascular mortality [ Time Frame: 30 months ]
    Based on self-reporting and Norwegian Registries
  • Incidence of cancer [ Time Frame: 6 months ]
    Based on self-reporting and Norwegian Registries
  • Incidence of cancer [ Time Frame: 30 months ]
    Based on self-reporting and Norwegian Registries
  • Incidence of cancer mortality [ Time Frame: 6 months ]
    Based on self-reporting and Norwegian Registries
  • Incidence of cancer mortality [ Time Frame: 30 months ]
    Based on self-reporting and Norwegian Registries
  • All-cause mortality [ Time Frame: 6 months ]
    Based on self-reporting and Norwegian Registries
  • All-cause mortality [ Time Frame: 30 months ]
    Based on self-reporting and Norwegian Registries
  • Incidence of fracture of the hip or forearm [ Time Frame: 6 months ]
    Based on self-reporting and Norwegian Registries
  • Incidence of fracture of the hip or forearm [ Time Frame: 30 months ]
    Based on self-reporting and Norwegian Registries
  • Incident dementia [ Time Frame: 6 months ]
    Based on self-reporting and Norwegian Registries
  • Incident dementia [ Time Frame: 30 months ]
    Based on self-reporting and Norwegian Registries
  • 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)
  • 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.
  • 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.
  • 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
  • Number of participants with self-reported cod liver oil related adverse events [ Time Frame: 12 months ]
    Number of participants with self-reported adverse events
  • 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
Original Other Pre-specified Outcome Measures
 (submitted: October 28, 2020)
  • Incidence of Cardiovascular disease [ Time Frame: 6 months ]
    Based on self-reporting and Norwegian Registries
  • Incidence of Cardiovascular disease [ Time Frame: 30 months ]
    Based on self-reporting and Norwegian Registries
  • Incidence of cardiovascular mortality [ Time Frame: 6 months ]
    Based on self-reporting and Norwegian Registries
  • Incidence of cardiovascular mortality [ Time Frame: 30 months ]
    Based on self-reporting and Norwegian Registries
  • Incidence of cancer [ Time Frame: 6 months ]
    Based on self-reporting and Norwegian Registries
  • Incidence of cancer [ Time Frame: 30 months ]
    Based on self-reporting and Norwegian Registries
  • Incidence of cancer mortality [ Time Frame: 6 months ]
    Based on self-reporting and Norwegian Registries
  • Incidence of cancer mortality [ Time Frame: 30 months ]
    Based on self-reporting and Norwegian Registries
  • All-cause mortality [ Time Frame: 6 months ]
    Based on self-reporting and Norwegian Registries
  • All-cause mortality [ Time Frame: 30 months ]
    Based on self-reporting and Norwegian Registries
  • Fracture of the hip or forearm [ Time Frame: 6 months ]
    Based on self-reporting and Norwegian Registries
  • Fracture of the hip or forearm [ Time Frame: 30 months ]
    Based on self-reporting and Norwegian Registries
  • Incident dementia [ Time Frame: 6 months ]
    Based on self-reporting and Norwegian Registries
  • Incident dementia [ Time Frame: 30 months ]
    Based on self-reporting and Norwegian Registries
  • 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)
  • 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.
  • 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.
  • 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
  • Number of participants with self-reported cod liver oil related adverse events [ Time Frame: 12 months ]
    Number of participants with self-reported adverse events
  • 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
 
Descriptive Information
Brief Title  ICMJE Cod Liver Oil for Covid-19 Prevention Study
Official Title  ICMJE 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
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE 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
Condition  ICMJE
  • Covid-19
  • Respiratory Tract Infections
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: Cod liver oil
    supplementation for 6 months
    Intervention: Dietary Supplement: Cod liver oil
  • Placebo Comparator: Corn oil (placebo)
    supplementation for 6 months
    Intervention: Dietary Supplement: Corn oil (placebo)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 28, 2020)
80000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2023
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Arne Søraas, MD, PhD +4790652904 arvsoe@ous-hf.no
Contact: John Arne Dahl, PhD +4741456596 j.a.dahl@medisin.uio.no
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04609423
Other Study ID Numbers  ICMJE REK-172796
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
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.
Responsible Party Arne Vasli Lund Søraas, Oslo University Hospital
Study Sponsor  ICMJE Oslo University Hospital
Collaborators  ICMJE
  • University of Oslo
  • Norwegian Institute of Public Health
Investigators  ICMJE
Principal Investigator: Arne Søraas, MD, PhD Oslo University Hospital
PRS Account Oslo University Hospital
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP