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| Name | Class |
|---|---|
| University of Oslo | OTHER |
| Norwegian Institute of Public Health | OTHER_GOV |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cod liver oil | Experimental | supplementation for 6 months |
|
| Corn oil (placebo) | Placebo Comparator | supplementation for 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cod liver oil | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Number of participants with self-reported airway infection |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants hospitalized due to Covid-19 | Number of participants hospitalized wholly or partly caused by Covid-19. | 6 months |
| Number of participants in Intensiv Care Unit (ICU) caused by Covid-19 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Cardiovascular disease | Based on self-reporting and Norwegian Registries | 6 months |
| Incidence of Cardiovascular disease | Based on self-reporting and Norwegian Registries |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arne Søraas, MD, PhD | Oslo University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo University Hospital | Oslo | 0424 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36215222 | Derived | 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. |
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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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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: Study Protocol version 1.2 without Statistical Analysis Plan | Nov 10, 2021 | Nov 26, 2021 | Prot_SAP_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: Statistical Analysis Plan version 1.0, signed | Dec 10, 2021 | Dec 13, 2021 | SAP_003.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D012141 | Respiratory Tract Infections |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D007239 | Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| D003060 | Cod Liver Oil |
| D014807 | Vitamin D |
| D012343 | RNA, Transfer |
| D003314 | Corn Oil |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
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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
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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.
|
|
| 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 |
|
The number of episodes with any two of the following symptoms: fever, cough, nasal congestion or sore throat
| 6 months |
Number of participants with ICU care wholly or partly caused by Covid-19.
| 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. | 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. | 6 months |
| Number of visits at GP for infections | Based on The Norwegian Reimbursement Database | 6 months |
| Number of visits at GP | Based on The Norwegian Reimbursement Database | 6 months |
| 30 months |
| Incidence of cardiovascular mortality | Based on self-reporting and Norwegian Registries | 6 months |
| Incidence of cardiovascular mortality | Based on self-reporting and Norwegian Registries | 30 months |
| Incidence of cancer | Based on self-reporting and Norwegian Registries | 6 months |
| Incidence of cancer | Based on self-reporting and Norwegian Registries | 30 months |
| Incidence of cancer mortality | Based on self-reporting and Norwegian Registries | 6 months |
| Incidence of cancer mortality | Based on self-reporting and Norwegian Registries | 30 months |
| All-cause mortality | Based on self-reporting and Norwegian Registries | 6 months |
| All-cause mortality | Based on self-reporting and Norwegian Registries | 30 months |
| Incidence of fracture of the hip or forearm | Based on self-reporting and Norwegian Registries | 6 months |
| Incidence of fracture of the hip or forearm | Based on self-reporting and Norwegian Registries | 30 months |
| Incident dementia | Based on self-reporting and Norwegian Registries | 6 months |
| Incident dementia | Based on self-reporting and Norwegian Registries | 30 months |
| 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 |
| 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 |
| 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 |
| Self-reported airway infection | The number of episodes with any two of the following symptoms: fever, cough, nasal congestion or sore throat | 12 months |
| Number of participants with self-reported cod liver oil related adverse events | Number of participants with self-reported adverse events | 12 months |
| 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 |
| D018352 |
| Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005224 |
| Fats, Unsaturated |
| D005395 | Fish Oils |
| D009821 | Oils |
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D012313 | RNA |
| D009696 | Nucleic Acids |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D010938 | Plant Oils |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |