Cod Liver Oil for Covid-19 Prevention Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

47210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-10

Study Completion Date

2021-06-02

Brief Summary

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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.

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Detailed Description

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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

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Covid-19 Respiratory Tract Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Study Groups

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Cod liver oil

supplementation for 6 months

Group Type EXPERIMENTAL

Cod liver oil

Intervention Type 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.

Corn oil (placebo)

supplementation for 6 months

Group Type PLACEBO_COMPARATOR

Corn oil (placebo)

Intervention Type DIETARY_SUPPLEMENT

5 ml of corn oil per day for 6 months x 1 time/day together with the first meal of the day

Interventions

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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.

Intervention Type 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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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10 ug of vitamin D and 1 g n-3 LCPUFA Tran

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes