Cod Liver Oil for Covid-19 Prevention Study

NCT04609423 | Completed Phase 4

• 1 other identifier: REK-172796
• Study Type: interventional
• Target: 47,210
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid-19; Respiratory Tract Infections

Keywords

Cod liver oil; Vitamin D; n-3 LCPUFAs; SARS-CoV virus

Outcome Measures

Primary Outcomes (4)

• 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

  The number of episodes with any two of the following symptoms: fever, cough, nasal congestion or sore throat

  6 months

Secondary Outcomes (6)

• Number of participants hospitalized due to Covid-19

  6 months

• Number of participants in Intensiv Care Unit (ICU) caused by Covid-19

  6 months

• Number of participants with any admissions to hospital

  6 months

• Infection with each of the mentioned pathogens

  6 months

• Number of visits at GP for infections

  6 months

Other Outcomes (20)

• Incidence of Cardiovascular disease

  6 months

• Incidence of Cardiovascular disease

  30 months

• Incidence of cardiovascular mortality

  6 months

Study Arms (2)

Cod liver oil

EXPERIMENTAL

supplementation for 6 months

Dietary Supplement: Cod liver oil

Corn oil (placebo)

PLACEBO COMPARATOR

supplementation for 6 months

Dietary Supplement: Corn oil (placebo)

Interventions

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.

Also known as: 10 ug of vitamin D and 1 g n-3 LCPUFA, Tran

Cod liver oil

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

Corn oil (placebo)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• Difficulty in swallowing cod liver oil or other oils
• Previous Covid-19 disease

Sponsors & Collaborators

• Oslo University Hospital: lead
• University of Oslo: collaborator
• Norwegian Institute of Public Health: collaborator

Study Sites (1)

Oslo University Hospital

Oslo, 0424, Norway

Location

Related Publications (1)

• 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.

  PMID: 36215222 DERIVED

MeSH Terms

Conditions

COVID-19; Respiratory Tract Infections

Interventions

Cod Liver Oil; Vitamin D; RNA, Transfer; Corn Oil

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Fish Oils; Oils; Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; RNA; Nucleic Acids; Nucleic Acids, Nucleotides, and Nucleosides; Plant Oils; Plant Preparations; Biological Products; Complex Mixtures; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Arne Søraas, MD, PhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MD, PhD

Model Details: 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

Study Record Dates

• First Submitted: October 22, 2020
• First Posted: October 30, 2020
• Study Start: November 10, 2020
• Primary Completion: June 2, 2021
• Study Completion: June 2, 2021
• Last Updated: April 6, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)