The authors randomly assigned people to either get treatment as usual or calcifediol, which is a product of vitamin D metabolism, and then checked how many went into ICU or died in the two groups
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The findings were, to put it bluntly, astonishing Of the intervention group, only 1/50 patients went to ICU Of the control, 13/50 went to ICU, 2 of whom died So calcifediol reduced ICU admission by ~90%!pic.twitter.com/h9hSt4cL11
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However, it doesn't take long to see some major caveats to this research Firstly, it was not blinded. Treating clinicians - who were the ones in charge of sending a patient to ICU - knew who was getting the treatment and who wasn't
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There was also no placebo control, again introducing a potential source of bias into the arrangement On top of this, the sample was very small (n=76)
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Now, all of this is fine, because you see this was a PILOT trial The actual big research project is ongoing, and will involve >10x as many people!pic.twitter.com/cHPCo0z4P1
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But there are some issues in the study that don't have anything to do with the pilot nature For example, this flow diagrampic.twitter.com/J3c0GQSSQC
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This diagram implies that of the patients who were screened for the study (PCR+, pneumonia on radiograph, clinical infection) 100% were enrolled 100% of those patients were randomized 100% took the treatment as assigned 100% were followed up until the end of the study
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Now, I don't know if that is entirely unheard of, but thus far I have never seen such perfect numbers. Even other in-hospital trials of drugs for COVID-19 have a handful of patients drop out (or at least 1 patient screened who was not eligible!)
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Also, the control group had higher levels of hypertension and diabetes compared to the intervention group. This is acknowledged by the authors as a limitation, and is definitely not ideal when making conclusions based on the resultspic.twitter.com/XM3KjauodY
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It is entirely possible - perhaps even likely - that one of these potential sources of bias influenced the eventual results. A study like this would be rated as at a "very high" risk of bias in most formal assessments
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I think most scientists would just read this as a tiny pilot study, and await better data That's certainly my opinion - there are too many potential sources of bias here to make any solid conclusions
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Unfortunately, it is the age of COVID-19, so this study has instead gone viral on social media and is being used to recommend that people take vitamin D supplements Such is the way of 2020
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I should also mention that this is not in any way an indictment of the study's authors. This was clearly meant to be a pilot study, and should be read as such It is just a shame that people have instead sensationalized the research
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