Covid-19Phase 4NCT04609423
Cod Liver Oil for Covid-19 Prevention Study
A Phase 4 study testing Cod liver oil in people with Covid-19 and Respiratory Tract Infections, run by Oslo University Hospital at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid-19, Respiratory Tract Infections
- What is being tested?
- Cod liver oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47,210 participants
- Where
- 1 siteNorway
- Study dates
- 10 Nov 2020to 2 Jun 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Any person >18 years with a Norwegian Personal Identity Number
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Covid-19, Respiratory Tract Infections
- Being tested
- Cod liver oil, Corn oil (placebo)
- Keywords
- Cod liver oil, Vitamin D, n-3 LCPUFAs, SARS-CoV virus
- Medical subject headings
- COVID-19, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cod liver oilDietary supplement
Also called 10 ug of vitamin D and 1 g n-3 LCPUFA, Tran
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)Dietary supplement
5 ml of corn oil per day for 6 months x 1 time/day together with the first meal of the day
| Study group | Role | What they receive |
|---|---|---|
| Cod liver oil | Experimental | supplementation for 6 months Receives: Dietary Supplement: Cod liver oil |
| Corn oil (placebo) | Placebo comparator | supplementation for 6 months Receives: Dietary Supplement: Corn oil (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- 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)
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
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
Measured: 6 months
Secondary outcomes (6)
Number of participants hospitalized due to Covid-19
Number of participants hospitalized wholly or partly caused by Covid-19.
Measured: 6 months
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.
Measured: 6 months
Number of participants with any admissions to hospital
Number of participants with any admissions to hospital based on the Norwegian Patient Registry data.
Measured: 6 months
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.
Measured: 6 months
Number of visits at GP for infections
Based on The Norwegian Reimbursement Database
Measured: 6 months
Number of visits at GP
Based on The Norwegian Reimbursement Database
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2020
- Study start10 Nov 2020
- Primary completion2 Jun 2021
- Study completion2 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid-19Studies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 47,210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo, Norwegian Institute of Public Health
- Responsible party
- Principal investigator, Arne Vasli Lund Søraas, Oslo University Hospital
- Investigators
- Arne Søraas, MD, PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04609423
- Sponsor's protocol ID
- REK-172796
- Status last verified
- Mar 2022
- First submitted
- 22 Oct 2020
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Brunvoll SH, Nygaard AB, Ellingjord-Dale M, Holland P, Istre MS, Kalleberg KT, Soraas CL, Holven KB, Ulven SM, Hjartaker A, Haider T, Lund-Johansen F, Dahl JA, Meyer HE, Soraas A. Prevention of covid-19 and other acute respiratory infections with cod liver oil supplementation, a low dose vitamin D supplement: quadruple blinded, randomised placebo controlled trial. BMJ. 2022 Sep 7;378:e071245. doi: 10.1136/bmj-2022-071245.
PubMed 36215222
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04609423
- Acronym / sponsor ID
- REK-172796
- Conditions
- Covid-19, Respiratory Tract Infections
- Keywords
- Cod liver oil, Vitamin D, n-3 LCPUFAs, SARS-CoV virus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47,210 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- University of Oslo, Norwegian Institute of Public Health
- Study start
- 10 Nov 2020 (actual)
- Primary completion
- 2 Jun 2021 (actual)
- Study completion
- 2 Jun 2021 (actual)
- First posted
- 30 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Cod liver oil | Experimental | Dietary Supplement: Cod liver oilsupplementation for 6 months |
| Corn oil (placebo) | Placebo comparator | Dietary Supplement: Corn oil (placebo)supplementation for 6 months |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any person >18 years with a Norwegian Personal Identity Number
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cod liver oilAlso: 10 ug of vitamin D and 1 g n-3 LCPUFA, Tran5 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. | Dietary supplement | Cod liver oil |
| 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 | Dietary supplement | Corn oil (placebo) |
Primary outcome
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 negative SARS-CoV-2 test
Time frame: 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.
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
6 secondary outcomes
Number of participants hospitalized due to Covid-19
Time frame: 6 months
Number of participants in Intensiv Care Unit (ICU) caused by Covid-19
Time frame: 6 months
Number of participants with any admissions to hospital
Time frame: 6 months
Infection with each of the mentioned pathogens
Time frame: 6 months
Number of visits at GP for infections
Time frame: 6 months
Number of visits at GP
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- Derived from this study: PubMed 36215222Brunvoll SH, Nygaard AB, Ellingjord-Dale M, Holland P, Istre MS, Kalleberg KT, Soraas CL, Holven KB, Ulven SM, Hjartaker A, Haider T, Lund-Johansen F, Dahl JA, Meyer HE, Soraas A. Prevention of covid-19 and other acute respiratory infections with cod liver oil supplementation, a low dose vitamin D supplement: quadruple blinded, randomised placebo controlled trial. BMJ. 2022 Sep 7;378:e071245. doi: 10.1136/bmj-2022-071245.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arne Søraas, MD, PhD principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cod liver oil in people with Covid-19 and Respiratory Tract Infections, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants diagnosed with serious Covid-19 (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04609423, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2022.