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0 0.5 1 1.5 2+ ICU admission -0% Improvement Relative Risk Hospitalization 11% Severe case -20% Case 0% Brunvoll et al. NCT04609423 Vitamin D RCT Prophylaxis Is prophylaxis with vitamin D+cod liver oil beneficial for COVID-19? Double-blind RCT 34,601 patients in Norway (November 2020 - June 2021) Higher severe cases with vitamin D+cod liver oil (not stat. sig., p=0.17) Very low dose vitamin D, relatively high D levels for both groups Brunvoll et al., BMJ, doi:10.1136/bmj-2022-071245 Favors vitamin D Favors control
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
Brunvoll et al., Prevention of covid-19 and other acute respiratory infections with cod liver oil supplementation, a low dose.., BMJ, doi:10.1136/bmj-2022-071245, NCT04609423
Sep 2022   Source   PDF  
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RCT 17,278 low-risk patients (zero mortality) treated with 5mL/day cod liver oil (~400IU vitamin D) and 17,323 placebo patients in Norway with, showing no significant differences with treatment. The placebo group had higher vitamin D at baseline, and both groups had comparable vitamin D during treatment (74 vs. 63 nmol/L). 23% of control patients took vitamin D supplements and 62% consumed fatty fish (typically a good source of vitamin D). Adherence was low (<70% for "strict" compliance, which only required >0.5L consumed, or treatment for > "2-3" months).
risk of ICU admission, 0.3% higher, RR 1.00, p = 1.00, treatment 4 of 17,278 (0.0%), control 4 of 17,323 (0.0%).
risk of hospitalization, 10.9% lower, RR 0.89, p = 1.00, treatment 8 of 17,278 (0.0%), control 9 of 17,323 (0.1%), NNT 17692.
risk of severe case, 20.0% higher, RR 1.20, p = 0.17, treatment 121 of 17,278 (0.7%), control 101 of 17,323 (0.6%).
risk of case, no change, RR 1.00, p = 0.98, treatment 227 of 17,278 (1.3%), control 228 of 17,323 (1.3%), NNT 42377.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Brunvoll et al., 7 Sep 2022, Double Blind Randomized Controlled Trial, placebo-controlled, Norway, peer-reviewed, mean age 44.9, 15 authors, study period 10 November, 2020 - 2 June, 2021, dosage 400IU daily, this trial uses multiple treatments in the treatment arm (combined with cod liver oil) - results of individual treatments may vary, trial NCT04609423 (history).
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This PaperVitamin DAll
Abstract: RESEARCH Sonja H Brunvoll,1 Anders B Nygaard,1 Merete Ellingjord-Dale,1 Petter Holland,1 Mette Stausland Istre,1 Karl Trygve Kalleberg,2 Camilla L Søraas,3 Kirsten B Holven,4,5 Stine M Ulven,4 Anette Hjartåker,4 Trond Haider,6 Fridtjof Lund-Johansen,7 John Arne Dahl,1 Haakon E Meyer,8,9 Arne Søraas1 For numbered affiliations see end of the article Correspondence to: A Søraas (ORCID 0000-0003-1622-591X) Additional material is published online only. To view please visit the journal online. Cite this as: BMJ 2022;378:e071245 bmj‑2022‑071245 Accepted: 19 July 2022 Abstract 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. What is already known on this topic Vitamin D has been suggested as having a role in the prevention of covid-19, but most studies have been observational A recent meta-analysis of 46 randomised controlled trials showed that vitamin D supplementation decreased the risk of acute respiratory infections compared with placebo, but the effect was small What this study adds Of 34 601 unselected adult participants, no difference in the incidence of SARSCoV-2 infection, serious covid-19, or acute respiratory infections was found for those randomised to daily supplements of low dose vitamin D (cod liver oil) or placebo (corn oil) during the winter The cod liver oil and placebo group had similar side effects, and only low grade side effects were reported the bmj | BMJ 2022;378:e071245 | doi: 10.1136/bmj-2022-071245 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..
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