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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.

  • 2022-09-07
  • BMJ (Clinical research ed.) 378
    • Sonja H Brunvoll
    • Anders B Nygaard
    • Merete Ellingjord-Dale
    • Petter Holland
    • Mette Stausland Istre
    • Karl Trygve Kalleberg
    • Camilla L Søraas
    • Kirsten B Holven
    • Stine M Ulven
    • Anette Hjartåker
    • Trond Haider
    • Fridtjof Lund-Johansen
    • John Arne Dahl
    • Haakon E Meyer
    • Arne Søraas

Study Design

Type
Randomized Controlled Trial (RCT)
Sample size
n = 601
Population
34 601 adults (aged 18-75 years), not taking daily vitamin D supplements
Methods
Quadruple blinded, randomised placebo controlled trial; 5 mL/day of cod liver oil (10 µg of vitamin D) or placebo for up to six months
Blinding
Triple-blind
Duration
up to six months
Funding
Unclear
  • Large Human Trial

Objective

To determine if daily supplementation with cod liver oil, a low dose vitamin D supplement, in winter, prevents SARS-CoV-2 infection, serious covid-19, or other acute respiratory infections in adults in Norway.

Design

Quadruple blinded, randomised placebo controlled trial.

Setting

Norway, 10 November 2020 to 2 June 2021.

Participants

34 601 adults (aged 18-75 years), not taking daily vitamin D supplements.

Intervention

5 mL/day of cod liver oil (10 µg of vitamin D, n=17 278) or placebo (n=17 323) for up to six months.

Main outcome measures

Four co-primary endpoints were predefined: the first was a positive SARS-CoV-2 test result determined by reverse transcriptase-quantitative polymerase chain reaction and the second was serious covid-19, defined as self-reported dyspnoea, admission to hospital, or death. Other acute respiratory infections were indicated by the third and fourth co-primary endpoints: a negative SARS-CoV-2 test result and self-reported symptoms. Side effects related to the supplementation were self-reported. The fallback method was used to handle multiple comparisons.

Results

Supplementation with cod liver oil was not associated with a reduced risk of any of the co-primary endpoints. Participants took the supplement (cod liver oil or placebo) for a median of 164 days, and 227 (1.31%) participants in the cod liver oil group and 228 (1.32%) participants in the placebo group had a positive SARS-CoV-2 test result (relative risk 1.00, multiple comparison adjusted confidence interval 0.82 to 1.22). Serious covid-19 was identified in 121 (0.70%) participants in the cod liver oil group and in 101 (0.58%) participants in the placebo group (1.20, 0.87 to 1.65). 8546 (49.46%) and 8565 (49.44%) participants in the cod liver oil and placebo groups, respectively, had ≥1 negative SARS-CoV-2 test results (1.00, 0.97 to 1.04). 3964 (22.94%) and 3834 (22.13%) participants in the cod liver oil and placebo groups, respectively, reported ≥1 acute respiratory infections (1.04, 0.97 to 1.11). Only low grade side effects were reported in the cod liver oil and placebo groups.

Conclusion

Supplementation with cod liver oil in the winter did not reduce the incidence of SARS-CoV-2 infection, serious covid-19, or other acute respiratory infections compared with placebo.

Trial registration

ClinicalTrials.gov NCT04609423.

Research Insights

  • Cod Liver Oil→Reduced Acute Respiratory Infection

    3964 (22.94%) and 3834 (22.13%) participants in the cod liver oil and placebo groups, respectively, reported ≥1 acute respiratory infections (1.04, 0.97 to 1.11).

    Effect
    Neutral
    Effect size
    Small
    Dose
    5 mL/day (10 µg vitamin D)
  • Cod Liver Oil→Reduced SARS-CoV-2 Infection

    227 (1.31%) participants in the cod liver oil group and 228 (1.32%) participants in the placebo group had a positive SARS-CoV-2 test result (relative risk 1.00, multiple comparison adjusted confidence interval 0.82 to 1.22).

    Effect
    Neutral
    Effect size
    Small
    Dose
    5 mL/day (10 µg vitamin D)
  • Cod Liver Oil→Reduced Severe COVID-19

    Serious covid-19 was identified in 121 (0.70%) participants in the cod liver oil group and in 101 (0.58%) participants in the placebo group (1.20, 0.87 to 1.65).

    Effect
    Neutral
    Effect size
    Small
    Dose
    5 mL/day (10 µg vitamin D)

Adverse Events Reported

  • Cod Liver Oil→side effects

    Only low grade side effects were reported in the cod liver oil and placebo groups.

    Finding
    Reported
    Grade
    mild
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